Evaluation of the efficacy and safety of two formulations of Ipratropium bromide HFA pMDI in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
S. Naik, J. Rebello, N. Morde, R. Mehta, S. Bhargava, S. Balamurugan, G. Malhotra, S. Chachad, A. Lulla, S. Purandare (Mumbai, Indore, Chennai, India)
Source: Annual Congress 2010 - COPD: treatment and monitoring
Session: COPD: treatment and monitoring
Session type: Thematic Poster Session
Number: 1318
Disease area: Airway diseases
Abstract INTRODUCTION: A generic formulation of Ipratropium bromide HFA pMDI(Test IB) 20 µg/actuation has been developed by Cipla Ltd. This study evaluated the safety and efficacy of test IB against ipratropium bromide HFA pMDI (Atrovent (reference IB), Boerhinger Ingelheim, UK) OBJECTIVE: To compare the efficacy and safety of the test IB with the reference IB in patients with COPD.METHODOLOGY: This was a randomised, double-blind, double dummy, parallel group, multicentre study with run-in period of 2-weeks, followed by a 12-week treatment period. Eligible patients with an FEV1 ≥ 50% & ≤ 80% pred and FEV1 /FVC ratio < 70% were randomised to either test or reference product 2 puffs thrice daily. The primary endpoint was peak FEV1 (at 90 min post dose) on day 85 after randomisation. The secondary endpoints were FVC, symptom score, rescue medication use and St. George‘s Respiratory Questionnaire (SGRQ). Reporting of adverse events, lab investigations, and vital signs were carried out to assess safety.RESULTS: For the ITT (n = 395), & PP population (n = 258), the test IB was non inferior to the reference IB as the lower limit of the two sided 95% CI for the change in peak FEV1 was greater than – 100 ml (predefined non inferiority limit), 95 % CI for PP population (-0.0408, 0.040) & ITT population (-0.0484, 0.0261). All the secondary endpoints and safety endpoints were comparable between the two groups. Conclusion: The test product, Ipratropium bromide HFA pMDI is non-inferior to the reference product, in improving lung function and symptoms of COPD. Both the HFA formulations were safe and well tolerated
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S. Naik, J. Rebello, N. Morde, R. Mehta, S. Bhargava, S. Balamurugan, G. Malhotra, S. Chachad, A. Lulla, S. Purandare (Mumbai, Indore, Chennai, India). Evaluation of the efficacy and safety of two formulations of Ipratropium bromide HFA pMDI in patients with mild to moderate chronic obstructive pulmonary disease (COPD). Eur Respir J 2010; 36: Suppl. 54, 1318
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