Tiotropium Research Articles

Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database

BackgroundDrug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. MethodsWe accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs. ResultsA total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts. ConclusionTiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.

Clinical Efficacy Observation of Acetylcysteine Combined with Tiotropium Bromide Inhalation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a common inflammatory airway disease. When acute exacerbations occur in patients, their pulmonary function (PF) and quality of life (QOL) will be adversely affected, with patient mortality closely related to the frequency and severity of the episodes. This study mainly focuses on the clinical efficacy of acetylcysteine (AC) combined with tiotropium bromide (TB) inhalation for acute exacerbations of COPD (AECOPD). First, 110 patients with AECOPD admitted between February 2019 and February 2021 were selected, of whom 51 cases treated with TB inhalation alone were set as the control group (the Con), and the other 59 cases using the combination therapy (AC+TB inhalation) were set as the observation group (the Obs). Subsequently, inter-group comparisons were performed in terms of clinical efficacy, symptom scores (e.g., cough, expectoration, and dyspnea), PF (e.g., total lung volume [TLC], forced expiratory volume in 1 s [FEV1], and peak expiratory flow [PEF]), inflammatory factors (IFs; e.g., high-sensitivity C-reactive protein [hs-CRP], interleukin-18 [IL-18], matrix metalloproteinase-2 [MMP-2]), and QOL (St. George’s Respiratory Questionnaire [SGRQ]). The Obs had higher overall treatment efficacy and lower symptom (e.g., cough, expectoration, and dyspnea) scores than the Con. Furthermore, the Obs exhibited statistically lower hs-CRP, IL-18, and MMP-2 levels and SGRQ scores and higher TLC, FEV1, and PEF than the Con after treatment. AC+TB inhalation is superior to TB inhalation alone in treating patients with AECOPD, thereby improving patients’ clinical symptoms, PF, and QOL, while inhibiting IFs, including hs-CRP, IL-18, and MMP-2.

Integration of mucus and its impact within in vitro setups for inhaled drugs and formulations: Identifying the limits of simple vs. complex methodologies when studying drug dissolution and permeability

Traditionally, developing inhaled drug formulations relied on trial and error, yet recent technological advancements have deepened the understanding of ‘inhalation biopharmaceutics’ i.e. the processes that occur to influence the rate and extent of drug exposure in the lungs. This knowledge has led to the development of new in vitro models that predict the in vivo behavior of drugs, facilitating the enhancement of existing formulation and the development of novel ones. Our prior research examined how simulated lung fluid (SLF) affects the solubility of inhaled drugs. Building on this, we aimed to explore drug dissolution and permeability in lung mucosa models containing mucus. Thus, the permeation of four active pharmaceutical ingredients (APIs), salbutamol sulphate (SS), tiotropium bromide (TioBr), formoterol fumarate (FF) and budesonide (BUD), was assayed in porcine mucus covered Calu-3 cell layers, cultivated at an air liquid interface (ALI) or submerged in a liquid covered (LC) culture system. Further analysis on BUD and FF involved their transport in a mucus-covered PAMPA system. Finally, their dissolution post-aerosolization from Symbicort® was compared using ‘simple’ Transwell and complex DissolvIt® apparatuses, alone or in presence of porcine mucus or polymer-lipid mucus simulant. The presence of porcine mucus impacted both permeability and dissolution of inhaled drugs. For instance, permeability of SS was reduced by a factor of ten in the Calu-3 ALI model while the permeability of BUD was reduced by factor of two in LC and ALI setups. The comparison of dissolution methodologies indicated that drug dissolution performance was highly dependent on the setup, observing decreased release efficiency and higher variability in Transwell system compared to DissolvIt®. Overall, results demonstrate that relatively simple methodologies can be used to discriminate between formulations in early phase drug product development. However, for more advanced stages complex methods are required. Crucially, it was clear that the impact of mucus and selection of its composition in in vitro testing of dissolution and permeability should not be neglected when developing drugs and formulations intended for inhalation.

Effect of different doses of Budesonide combined with Tiotropium bromide inhalation on elderly patients with chronic obstructive pulmonary disease.

To explore the clinical effect of various doses of Budesonide combined with Tiotropium bromide in the treatment of elderly patients with chronic obstructive pulmonary disease (COPD). Clinical data of elderly patients with COPD, admitted to Affiliated Hospital of Shaoxing University from April 2021 to February 2023, were retrospectively analyzed. Based on the dosage of Budesonide combined with Tiotropium bromide, patients were divided into Low-dose group (Budesonide = 1mg), Medium-dose group (Budesonide = 2mg), and High-dose group (Budesonide = 3mg). All groups were matched for age, gender, course of disease, and BMI. Patients treated with Tiotropium bromide alone were assigned to the Control group. The clinical effect, pulmonary function index level, symptom improvement, inflammatory factor index level and adverse reactions in all groups were analyzed and compared. A total of 88 patients were included in this study with 22 patients in each group. The total efficacy of Medium-dose (90.91%) and High-dose group (90.91%) was significantly higher than that of Low-dose group (63.64%) and the Control group (59.09%) (P<0.05). After the treatment, levels of pulmonary function, symptom improvement and inflammatory factors in the High-dose and the Medium-dose groups were better than those in the Low-dose group and the Control group. Pulmonary function, symptom improvement and levels of inflammatory factors was significantly better in the Low-dose group compared to the Control group (P<0.05). Budesonide combined with tiotropium bromide is better than tiotropium bromide alone in the treatment of elderly patients with COPD. Compared with low (1mg) dosage, medium (2mg) and high (3mg) dosage of budesonide are more effective in improving lung function, alleviating symptoms, reducing inflammatory response,, and are not associated with increased rate of adverse reactions.

#1182 Arterial hypertension and chronic obstructive pulmonary disease—problems of choice of therapy

Abstract Background and Aims The development of hypertension in COPD is based on the early formation of endothelial dysfunction in the small and large circulatory circles, increased sympathetic activity with an imbalance in the synthesis of catecholamines, a violation of the role of the lungs in the metabolism of vasoactive substances, oxidative stress, chronic systemic inflammation, an imbalance in the renin-angiotensin-aldosterone system (RAAS). There are few studies confirming the role of RAAS components in the pathogenesis of cardiovascular changes in patients COPD. The activity of angiotensin converting enzyme (ACE) increases with hypoxia, which may play an important role in increasing the degree of systemic hypertension. An increase in the function of the RAAS is possible both under the direct influence of hypoxia and indirectly through activation of the sympathoadrenal system. To evaluate the efficacy and tolerability of the angiotensin II receptor antagonist valsartan (Nortivan) at a dose 80-160 mg per day in patients with hypertension of 1-2 degrees and COPD of stage II-IV. Method The study design is a local, open, incomparable study on the efficacy and safety of the drug Nortivan in patients with hypertension in combination with COPD. We examined 18 patients with stage II-IV in remission, suffering from grade I and II hypertension, determined in accordance with the generally accepted classification of blood pressure levels (VNOK, 2010). Results The criteria for exclusion from the study were the presence in patients of complications of hypertension, coronary heart disease, decompensated chronic pulmonary heart, endocrine diseases requiring drug correction, kidney pathology, chronic heart failure, oral steroid therapy. 10 days in the last 6 months before inclusion in the study, oncological diseases and any other conditions that could interfere with the interpretation and evaluation of the results of the study. Patients who had not previously received antihypertensive treatment were included in the study immediately, and the rest underwent a washing period for 2 weeks. Patients received Nortivan as antihypertensive therapy for 24 weeks. The effectiveness of therapy was controlled by daily monitoring blood pressure. The choice of quality criteria for the effectiveness of therapy parameters SMAD is associated with literature data and own observations on the prevalence of diurnal blood pressure profiles in patients with hypertension and COPD with no decrease or increase in blood pressure at night, when office blood pressure figures are to a lesser extent reflect the effectiveness of antihypertensive therapy. The initial dosage was 80 mg/day. With insufficient hypotensive effect, the dose of the drug was doubled at the 4th week of treatment. The basic COPD therapy did not change throughout the study period and included anticholinergic drugs (ipratropium bromide, tiotropium bromide), beta2-adrenomimetic (fe-noterol) or a combination thereof. Initially and after 24 weeks of treatment, a complete laboratory examination was performed: a clinical blood test, a biochemical blood test. The thickness of the intima-media complex of the carotid arteries and ECG was also studied. The criterion The safety of the therapy was assessed by the indicators of respiratory function, daily pulse oximetry. Conclusion The use of the drug Nortivan has shown high efficacy and safety in patients Grade I–II hypertension in combination with stage II-IV COPD. A statistically and clinically significant normalization of SMAD indicators with correction of pathological types of daily curves due to a decrease in the number of patients with an increase in or the absence of a decrease in blood pressure during the night period. The safety of using the drug in the clinical group with bronchial obstruction syndrome was confirmed by the dynamics of ventilation indicators according to spirometry and the results of daily pulse oximetry, which showed the absence of exacerbation of hypoxia during therapy.

Effects of co-application of tiotropium bromide and traditional Chinese medicine on patients with stable chronic obstructive pulmonary disease: a muilticenter, randomized, controlled trial study.

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease. Traditional Chinese Medicine (TCM) has shown promising potential in COPD treatment. and we conducted a multi-center RCT to evaluate the effectiveness of TCM-based therapy in stable COPD patients. In this multicenter, double-blind RCT, a total of 200 patients were supposed to be assigned to either trial or control group randomly. Both groups received Tiotropium (18 μg) from month 0 to month 12. Trial group received additional TCM granules, while control group received a placebo from month 0 to month 6. Symptom assessment, total effective rate, lung function measurements, hospitalization rates, and quality of life were evaluated at month 0, month 6, and month 12. Adverse events were assessed at month 12. Of the initial 105 patients (aged 40-80) who completed the study, 51 were in trial group and 54 were in control group. At month 6, significant differences were observed between two groups in total effective rate (p = 0.020), sputum score (p = 0.047), changes in FVC% (p = 0.047) and FEV1 (p = 0.046). At month 12, significant differences were observed in sputum score (p = 0.020), FVC (p = 0.042), and change in FEV1 (p = 0.013). Compared to baseline, they both demonstrated improvements in symptoms, acute exacerbation, lung function, quality of life, and exercise tolerance. TCM treatment effectively improved total effective rate, sputum symptom, FVC%, FEV1, and exhibited prolonged efficacy in improving sputum symptoms and FEV1 in stable COPD patients.Clinical trial registration:https://www.chictr.org.cn/showproj.html?proj=6029 identifier ChiCTR-TRC-13003531.

Retrospective Study on Prescription Pattern on the Management of Chronic Obstructive Pulmonary Disease (COPD)

Background: COPD is a disease caused by chronic bronchitis, emphysema, or combination of both conditions. As per the Global Burden of Disease 2017 prediction, COPD is the second leading cause of death in Nepal, the fourth leading cause of premature death and the third cause for disability-adjusted life years (DALYs) in Nepal. The prevalence of COPD in Nepal was 11.7%. If current situation prevails, the burden of COPD might increase continuously in the nation. Hence, the findings from this study might provide baseline information to medical and paramedical students and other researchers to conduct further study in similar area. Objectives: The study was done to assess the prescription pattern for management of COPD in multispecialty hospital of Nepal. Method: A retrospective study was conducted at 100 bedded multispecialty hospital located at Lalitpur, Nepal. A total of 200 inpatient records, from Baishak 2075 to Chaitra 2078 were reviewed and data was collected as per the objectives and analysed by using SPSS version 16 and MS Excel 2013. Result: Out of 200 COPD patients studied, female patients (58%) were higher than male patients and maximum patients (42.5%) were from the age group 70-79. The most common symptom was shortness of breath (77.5%) followed by cough (50%) and fever (33.5%) Hypertension (38.5%) was the most frequent co morbidity seen among COPD patients followed by corpulmonale (20%) and diabetes mellitus type II (19%). Doxophylline was the most prescribed methylxanthines during hospitalization (47.5%) and discharge (51%) as well. Among inhalers, Tiotropium bromide and combination of Salbutamol and Fluticasone (52.5%) was prescribed most to the hospitalised patients. Hydrocortisone (68.5%) was the most prescribed corticosteroids during hospitalization where as Prednisolone (49.5%) was the most prescribed corticosteroids during discharge. 85.5% of patients were prescribed Ipratropium bromide for nebulisation in hospitalised patients. Pantoprazole (55.5%) was the most prescribed proton pump inhibitors followed by Rabeprazole (34%). Maximum patients (103) preferred Rotacap than metered dose inhaler (MDI) and dry powder inhaler (DPI). Azithromycin (52.5%) was most frequently prescribed antibiotics during hospitalization followed by ceftriaxone (85%), whereas among discharge patients, Cefpodoxime (35%) was most frequently prescribed antibiotics followed by Azithromycin (32%). The drugs prescribed with generic name were 31.31% and from essential drug list (EDL) was 37.72 %. Conclusion: The prescription pattern of COPD was studied and found that Doxophylline, Tiotropium bromide, Hydrocortisone and Azithromycin were most prescribed methylxanthnes, antimuscarinic agents, corticosteroids and antibiotics respectively. The findings from the study showed that prescribing drugs with generic name and from EDL was low so prioritization on prescribing drugs by generic name and EDL needs to be encouraged.

A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)

BackgroundDespite the fundamental progress in hematopoietic stem cell transplant, this treatment is also associated with complications. Graft-versus-host disease is a possible complication of HSCT. Bronchiolitis obliterans syndrome (BOS) is the pulmonary form of this syndrome. Due to the high morbidity and mortality rate of BOS, various studies have been conducted in the field of drug therapy for this syndrome, although no standard treatment has yet been proposed. According to the hypotheses about the similarities between BOS and chronic obstructive pulmonary disease, the idea of using tiotropium bromide as a bronchodilator has been proposed.Method/designA randomized, double-blind, placebo-controlled, and crossover clinical trial is being conducted to evaluate the efficacy of tiotropium in patients with BOS. A total of 20 patients with BOS were randomly assigned (1:1) to receive a once-daily inhaled capsule of either tiotropium bromide (KP-Tiova Rotacaps 18 mcg, Cipla, India) or placebo for 1 month. Patients will receive tiotropium bromide or placebo Revolizer added to usual standard care. Measurements will include spirometry and a 6-min walking test.Ethics/disseminationThis study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical Science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with tiotropium is currently ongoing and is due to finish in April 2024. The authors will disseminate the findings in peer-reviewed publications, conferences, and seminar presentations.Trial registrationIranian Registry of Clinical Trial (IRCT) IRCT20200415047080N3. Registered on 2022–07-12, 1401/04/21.

Drug solubility in biorelevant media in the context of an inhalation-based biopharmaceutics classification system (iBCS)

An inhalation-based Biopharmaceutics Classification System for pulmonary drugs (iBCS) holds the perspective to allow for scientifically sound prediction of differences in the in vivo performance of orally inhaled drug products (OIDPs).A set of nine drug substances were selected, that are administered via both the oral and pulmonary routes. Their solubility was determined in media representative for the oral (Fasted State Simulated Intestinal Fluid (FaSSIF)) and pulmonary (Alveofact medium and Simulated Lung Fluid (SLF)) routes of administration to confirm the need for a novel approach for inhaled drugs. The complexity of these media was then stepwise reduced with the purpose of understanding the contribution of their components to the solubilizing capacity of the media. A second reason for varying the complexity was to identify a medium that would allow robust but accurate dissolution testing. Hence, Hank’s balanced salt solution (HBSS) as a medium used in many in vitro biological tests, non-buffered saline solution, and water were included.For some drug substances (salbutamol sulfate, tobramycin, isoniazid, and tiotropium bromide), no significant differences were observed between the solubility in the media used. For other drugs, however, we observed either just small (rifampicin, budesonide, salmeterol) or unexpectedly large differences (beclomethasone dipropionate).Based on the minimum theoretical solubility required for their common pulmonary dose in 10 ml of lung lining fluid, drug solubility was classified as either high or low. Two high solubility and two low solubility compounds were then selected for refined solubility testing in pulmonary relevant media by varying their content of phospholipids, surfactant proteins and other proteins.The solubility of drug substances in simulated lung lining fluids was found to be dependent on the physicochemical properties of the drug substance and the composition of the media. While a pulmonary dissolution medium that would fit all drugs could not be established, our approach may provide guidance for finding the most suitable dissolution medium for a given drug substance and better designing in vitro tests for predicting the in vivo performance of inhalable drug products.

Clinical Efficacy Analysis of Tiotropium Bromide Combined with Budesonide and Formoterol Inhalation in Treating COPD

Objective: To analyze the clinical efficacy of tiotropium bromide (TB) combined with budesonide formoterol (BUD/FM) inhalation in treating chronic obstructive pulmonary disease (COPD). Methods: 62 COPD patients admitted to the hospital between June 2020 and December 2022 were selected as samples for this study. The patients were divided into a combination group and a conventional group using the random number table method, with 31 cases in each group. The patients in the combination group were treated with TB combined with BUD/FM inhalation, whereas the patients in the conventional group were treated with BUD/FM inhalation only. The treatment efficacy and changes in lung function indicators of both groups were compared. Results: The total efficacy of treatment in the combined group was higher than that in the conventional group, and the difference was statistically significant (P &lt; 0.05). Before treatment, there was no difference in pulmonary function indicators between the two groups (P &gt; 0.05). After three months of treatment, all lung function indicators of the combined group were higher than those of the conventional group, and the difference was statistically significant (P &lt; 0.05). Conclusion: Combining TB with BUD/FM inhalation therapy increases the efficacy of treatment for patients with COPD. Besides, it also improves lung function and leads to a better prognosis.

Cost-utility of tiotropium in patients with severe asthma

SummaryAdd-on therapy with tiotropium was cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA in a middle-income country.BackgroundA significant proportion of asthma patients remain uncontrolled despite inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, such as tiotropium bromide, have been recommended for this subgroup of patients. This study aimed to assess the cost-effectiveness of tiotropium as an add-on therapy to inhaled corticosteroids and long-acting b2 agonists for patients with severe asthma.MethodsA probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. Total costs and QALYs of two interventions include standard therapy with inhaled corticosteroids and long-acting bronchodilators versus add-on therapy with tiotropium. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $5180.ResultsThe expected incremental cost per QALY (ICER) is estimated at US$–2637.59. There is a probability of 0.77 that tiotropium + ICS + LABA is more cost-effective than ICS + LABA at a threshold of US$5180 per QALY. The strategy with the highest expected net benefit is Tiotropium, with an expected net benefit of US$800. Our base-case results were robust to parameter variations in the deterministic sensitivity analyses.ConclusionAdd-on therapy with tiotropium was cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose inhaled corticosteroids and long-acting bronchodilators. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

Improved medication adherence in COPD patients using tiotropium or tiotropium olodaterol with the HealthPrize digital behavior change program

ABSTRACT Objective To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD). Methods In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015–31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs. Results Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72–3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs. Conclusions Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

СТАНДАРТИ ЛІКУВАННЯ ПАЦІЄНТІВ НА ХРОНІЧНЕ ОБСТРУКТИВНЕ ЗАХВОРЮВАННЯ ЛЕГЕНЬ, 2024 РІК: МІСЦЕ ТІОТРОПІУМА БРОМІДУ

Updated GOLD 2024 guidelines emphasized the problem of insufficient or inaccurate diagnosis of COPD, leading to inappropriate therapy of these patients. This trend is also widespread in Ukraine, despite the significant improvement in diagnosis and available treatment options. The aim of the study was to determine the effectiveness of tiotropium bromide (Spiriva® HandiHaler® "Boehringer Ingelheim Pharma GmbH", Germany) for the initial and follow-up treatment of patients. We evaluated the effect of the drug on the clinical and functional status of patients and adherence to therapy. Materials and methods. We enrolled 20 patients with newly diagnosed COPD (group 1) and 10 patients already receiving treatment with previously diagnosed COPD (group 2). In all group 2 patients the diagnosis was established in 2022-2023. In this study the diagnosis and initiation of treatment has been done according to GOLD 2024 recommendations. In 1 month of treatment the effectiveness of treatment based on the change of symptoms (mMRC dyspnea scale and CAT score) and treatment compliance were assessed. Results. Standard clinical examination was performed to confirm or revise of COPD diagnosis. In group 1 GOLD 2 airflow limitation were observed in 75 % (n = 15) of patients, GOLD 3 — in 25 % (n = 5); 25 % (n = 5) patients were classified as group A, and 75 % (n = 15) of patients — as group В. In group 2 there were prevalent the patients with more severe airflow limitation: GOLD 2 — 40 % (n = 4), GOLD 3 — 60 % (n = 6). All patients from this group were allocated to group B due to symptoms intensity. The analysis of CAT responses structure has demonstrated that the questions 1 to 4 evaluating such symptoms as cough and dyspnea collected more points. All patients received inhalation therapy with tiotropium bromide DPI once daily and Berodual H MDI as needed. In group 1 post-treatment CAT score demonstrated a significant change in comparison with visit 1 score (13,5 (SD 1,4) vs 11 (SD 1,0), р = 0,001). Conclusion. Overall, during the study period we observed a significant improvement in compliance, which was reflected in the decrease in the frequency of use of short-acting bronchodilators. The use of tiotropium bromide as an initial or follow-up therapy right after 1 month of treatment significantly reduced the clinical manifestations of the disease. Key words: chronic obstructive pulmonary disease, GOLD 2024, tiotropium bromide.

January 2024 Critical Care Case of the Month: I See Tacoma

No abstract available. Manuscript truncated after first 150 words. History of Present Illness An 80-year-old man was admitted to the hospital for exacerbation of COPD. He has a history of emphysema and has been on Breo Ellipta and Spiriva Respimat. He became increasingly short of breath although he had no productive cough. Past Medical History, Social History and Family History He has a past medical history of right upper lobe resection for an adenocarcinoma of the lung and a history of coronary artery bypass grafting and aortic valve replacement done about 5 years ago. He smoked ½ pack/day of cigarettes but quit 5 years ago. Medications He takes Warfarin for a history of atrial fibrillation and prosthetic aortic valve replacement. Physical Examination Other than dyspnea with tachypnea and decreased air movement on auscultation, as well as the expected right thoracic scar, his physical examination is unremarkable. Laboratory His arterial blood gases showed a PaO2 of 58, a PaCO2 of …

Efficacy and Safety Analysis of Salmeterol/Fluticasone Propionate with Tiotropium Bromide for Chronic Obstructive Pulmonary Disease

Efficacy and Safety Analysis of Salmeterol/Fluticasone Propionate with Tiotropium Bromide for Chronic Obstructive Pulmonary Disease

Omalizumab as a long-term treatment for patients with severe asthma. Is it safe?: A ten-year study

Abstract Background anti-IgE (Omalizumab) is one of the targeted therapies for severe bronchial asthma. Its real-life safety is still under scrutiny. The aim of the study was to evaluate the persistent efficacy and safety of Omalizumab as a long-term treatment of severe bronchial asthma. Patients and methods A prospective cohort study was conducted on 74 patients who had severe bronchial asthma eligible for Omalizumab subcutaneous treatment with a long-term regular follow-up to evaluate the long-term safety and efficacy of Omalizumab. Results This study was conducted on 74 patients who had severe bronchial asthma: 33 patients (44.6%) were males with a mean±SD (37.2 ± 4), and 41 females (55.4%) with a mean±SD (35.9 ± 6). Those patients were eligible for Omalizumab treatment with a long-term regular follow-up (from 7 to 10 years) to assess the long-term safety of Omalizumab. Omalizumab treatment has a significant improvement in the clinical condition of severe bronchial asthma as it decreased the number of patients who used oral steroids from 63 patients (before starting treatment) to 6 patients after 6 months of treatment, and 2 patients after 12 months of the dose. The use of tiotropium bromide had a significant decrease because the number of patients fell from 61 patients (before the start of treatment) to 13 patients after 6 months. It also reduced the number of acute exacerbations of bronchial asthma from 7 times per year (before the start of treatment) to 3 times after 6 months, and 2 times after 12 months of treatment. Patients’ pulmonary functions (FEV1, FEV1/ FVC, PEFR) improved significantly from (43.7 ± 9, 52.3 ± 11, 51.1 ± 4) before starting Omalizumab treatment to (64.1 ± 11,71.3 ± 13, 68.2 ± 7) after 6 months of usage; and to (69.4 ± 12, 73.3 ± 14, 72.1 ± 6) after 12 months of treatment. Long-term use of Omalizumab has less severe side effects as 70% of patients had injection site reactions in the form of local tenderness and swelling, 24.3% had a headache, 12% had nausea, 9.4% had myalgia, and 17.5% had a fever while the serious side effects as cancer, anaphylaxis or myocardial infarction has not recorded. All the side effects occurred in the first year of treatment. Conclusion Long term use of Omalizumab in severe bronchial asthma management has persistent efficacy and no serious side effects such as cancer, myocardial infarction or anaphylaxis and has only minimal side effects that occurred mostly in the first year of Omalizumab treatment, meaning that the physician cannot stop giving patients the medication.

Signal Mining and Analysis of Cardiovascular Adverse Events of Tiotropium Bromide Based on the FAERS Database

Signal Mining and Analysis of Cardiovascular Adverse Events of Tiotropium Bromide Based on the FAERS Database

Tiotropium bromide in the treatment of chronic obstructive pulmonary disease

The aim of this review was to analyze current information on tiotropium bromide as one of the LAMAs. Tiotropium was chronologically the first LAMA in clinical practice. It is administered using a dry powder inhaler or an aerosol inhaler (Respimat soft mist inhaler). Due to the long bronchodilator effect, tiotropium can be inhaled once a day. The drug has a significant effect on functional respiratory parameters, reduces lung hyperinflation, improves exercise tolerance and quality of life. Tiotropium is superior to short-acting bronchodilators and long-acting β2-agonists (LABAs) and is comparable to other LAMAs, as well as combinations of LABAs and inhaled corticosteroids in the prevention of COPD exacerbations. Tiotropium bromide has a favorable safety profile. Generic tiotropium drug products, including Respium®, are currently available in the Russian Federation. A clinical trial confirmed the non-inferiority and safety of generic tiotropium drug compared to the original branded product.Conclusion. Tiotropium is an effective and safe medication for the maintenance treatment of COPD and for reducing COPD exacerbations. The generic tiotropium drug products widen the range of effective inhaled medications available to physicians.

Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC-MS/MS.

Tiotropium Bromide is a long-acting bronchodilator that is used in the treatment of chronic obstructive pulmonary disease (COPD) and asthma bronchodilator or bronchiolitis, which are substances that expand the bronchi and reduce resistance in the respiratory tract and increase airflow to the lungs. For Tiotropium Bromide found in inhaler capsules to treat COPD, determining the relevant impurities G and H, which are not UV active, is crucial. For this purpose, a new and sensitive liquid chromatography triple-quadrupole mass spectrometry (LC-MS/MS) detection with electrospray ionization by using multiple reaction monitoring in the positive mode method was developed and validated. The identity of the compounds was supported by using LC-Q/TOF. All chromatographic studies were performed with a Zorbax Eclipse XDB-C8 (150 mm x 4.6 mm, 5.0 µm) column with a total injection time of 13 min at a flow rate of 0.4 ml/min as a gradient. The limit of detection (LOD) and limit of quantitation (LOQ) in the current study range were determined as 1.0 ppb and 2.5 ppb, respectively. The results of the validation parameters following the ICH Q2(R1) guideline were determined within the acceptance criteria.

Effect of bronchodilator therapy on the function of external respiration and lung parenchyma in surgical treatment of patients with non-small cell lung cancer combined with chronic obstructive pulmonary disease

The purpose of the study was to compare the efficacy of regular prolonged inhalation therapy with tiotropium bromide delivered via the Respimat inhaler and short-acting bronchodilator (SAB) therapy with ipratropium bromide/fenoterol in the perioperative period in patients with non-small cell lung cancer (NSCLC) combined with chronic obstructive pulmonary disease (copd).Material and Methods. The study included 66 patients with Nsclc and copd. The patients received tiotropium bromide, 5 mcg/day (TB group) or a combination of ipratropium bromide/fenoterol 20/50 mcg/dose, 2 doses 4 times a day (SAB group) for 6 weeks before and 6 weeks after surgery. The control group consisted of patients who did not receive bronchodilators before surgery, but they received a combination of ipratropium bromide/fenoterol in the postoperative period. All patients underwent tests of pulmonary function (spirometry, body plethysmography), measurement of lung parenchyma density and emphysematous lung areas (high-resolution computed tomography).Results. After preoperative preparation with use of tB or saB, there was a significant improvement in FEV1, FVC, VC, RV, ITGV, and. RV/TLC ratio relative to baseline. In the tB and sad groups, a significant reduction in the severity of total respiratory resistance (Rtot) compared to that in the control group was observed. According to the assessment of lung density and the volume of emphysematous areas on expiration, the results in the TB group were significantly better than those in the sad and control groups. six weeks after surgery, all patients showed a significant decrease in post-FeV1, post-FVC, and post-VC relative to the preoperative values. Bronchodilator therapy resulted in the reduction in Rtot in all groups; however, better results were achieved in the TB group (86 %) compared to sad group (93 %, p=0.03) and control (101.5 %, p=0.02). After surgical treatment, a decrease in the volume of emphysematous areas on inspiration was observed: the parameters were better in the TB group than in the sad and control groups (220 cm3 versus 1025 cm3 and 1002 cm3, p&lt;0.001 and p=0.002, respectively).Conclusion. In patients with Nsclc and copd, longterm inhaled bronchodilator therapy can significantly improve respiratory function. more beneficial results are achieved after using long-acting drugs (tiotropium bromide).