Health Condition 1: null- Chronic obstructive pulmonary disease
Conditions
Interventions
Intervention1: Ipratropium/salbutamol HFA pMDI: 2 puffs four times a day over 85 days
Control Intervention1: Ipratropium/salbutamol CFC pMDI: 2 puffs four times a day over 85 days
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a confirmed diagnosis of COPD according to the Global Initiative for Obstructive Lung Disease criteria who required regular treatment with both ipratropium bromide and salbutamol sulphate and were well controlled on the combination product and did not require additional β2-agonists as regular therapy. Study patients could be current smokers or ex-smokers. Eligible patients also demonstrated forced expiratory volume in one second (FEV1) greater than or equal to 50 percent of the predicted value and had an FEV1/FVC ratio prebronchodilator <70%. All patients gave written, informed consent.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they had a history of asthma, allergic rhinitis or atopy. Patients were also excluded if they had received hospital treatment for acute exacerbation or had other evidence of an acute exacerbation of COPD or if they had received systemic corticosteroids within 4 weeks of the screening visit. Other reasons for exclusion included any serious uncontrolled medical condition or clinically relevant condition or findings at screening that might have compromised the safety of the patients or that might have interfered with the study findings. Patient were also excluded if they were allergic to soyabean or peanuts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from pre dose FEV1 at 60 minutes after dosing on Day 85Timepoint: Change from pre dose FEV1 at 60 minutes after dosing on Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in St Georgeâ??s Respiratory Questionnaire scoreTimepoint: Assessed at baseline and at 12 weeks;Daytime and nighttime symptom scores Timepoint: Assessed at 1, 3, 6, 9 and 12 weeks after randomisation;Pre-dose FVCTimepoint: Assessed at clinic visits held at 1, 3, 6, 9 and 12 weeks after randomization;Total daily inhaled rescue medication Timepoint: Assessed at 1, 3, 6, 9 and 12 weeks after randomisation | — |
Countries
India
Contacts
Public ContactDr S Purandare
Cipla Ltd
Outcome results
None listed