ArticleAnnals of thoracic medicine
Evaluating the safety, tolerability, and efficacy of tulobuterol transdermal patch in patients with asthma or chronic obstructive pulmonary disease: A phase-IV clinical study.
Article in Annals of thoracic medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAsthma 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.
methodsThis 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
resultsOnly 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 (
conclusionTuloplast™ 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.
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