Evaluating the safety, tolerability, and efficacy of tulobuterol transdermal patch in patients with asthma or chronic obstructive pulmonary disease: A phase-IV clinical study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) contribute significantly to the global respiratory disease burden, with treatment adherence and nocturnal symptom control remaining key challenges. The Tulobuterol Transdermal Patch (Tuloplast™) provides continuous 24-h drug release, potentially improving adherence and symptom management. This Phase-IV clinical study evaluated its safety, tolerability, and efficacy in patients with asthma and COPD. METHODS: This multicentric, open-label Phase-IV trial enrolled 300 patients (189 asthma, 111 COPD) across seven Indian centers. Patients received Tuloplast™ in age-appropriate doses for 4–6 weeks. Primary endpoints included safety and tolerability, assessed by adverse events, global ratings, and rescue medication use. Efficacy (secondary endpoint) was evaluated through symptom severity (GINA/GOLD criteria) and pulmonary function (peak expiratory flow [PEF], forced expiratory volume in 1 second [FEV 1 ], forced vital capacity [FVC]), with statistical significance determined using paired t -tests. RESULTS: Only one patient (0.3%) reported an adverse event (mild swelling), with no serious safety concerns. At Day 28, 51.9% of asthma patients and 79.3% of COPD patients rated tolerability as “good,” while 43.9% and 12.6%, respectively, rated it “excellent.” Significant reductions in symptom severity were observed in asthma ( P < 0.0001) and COPD patients ( P < 0.0001), particularly for nocturnal symptoms (−74.88% for COPD, and −82.79% and −77.29% for pediatric and adolescent patients, respectively). Pulmonary function parameters (PEF, FEV 1 , FVC) improved significantly in both groups ( P < 0.0001). CONCLUSION: Tuloplast™ demonstrated excellent safety, tolerability, and efficacy in improving symptom control and lung function. Its once-daily application enhances adherence, making it a promising alternative for asthma and COPD management.
Source: Annals of Thoracic Medicine
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4413817133