Safety and Efficacy of Ipratropium + Salbutamol in Patients with COPD

18 Mar, 14

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Ipratropium + Salbutamol PMDI is Safe and Efective in Indian Copd Patients

Objective

To compare efficacy and safety of Ipratropium+Salbutamol-HFA pMDI (Duolin; 20/100 ?g; Cipla Ltd., India) versus Ipratropium+Salbutamol-CFC pMDI (Combivent; 20/100 ?g; Boehringer Ingelheim, UK).

Patients and Methods

Randomized, double-blind, parallel-group, multicentre study.
Subjects aged 40-75 years with confirmed diagnosis of COPD according to GOLD guidelines.
290 subjects were included and randomised to a 12 week treatment with 2 puffs four times a day of either Ipratropium+Salbutamol-HFA pMDI or Ipratropium+Salbutamol-CFC pMDI or a placebo pMDI.
The dose of the medication was administered and spirometry was performed before and 60 minutes post-dose.

Results

1. Efficacy

Non-inferiority of Ipratropium+Salbutamol-HFA pMDI to Ipratropium+Salbutamol-CFC pMDI was clearly demonstrated by change in FEV₁ from pre-dose at 60 minutes on day 85.

Change in FEV₁ (L/s) from pre-dose at 60 minutes on day 85

Mean values of FEV₁ over 12 weeks were similar for both the treatment groups (Ipratropium+Salbutamol-HFA pMDI vs. Ipratropium+Salbutamol-CFC pMDI).

Mean FEV₁ (L) over 12 weeks

2. Safety and Tolerability

The incidence of adverse events was similar in the two treatment groups.
Most common adverse events were headache, productive cough, cough and nasopharyngitis.

Conclusion

Ipratropium+Salbutamol-HFA pMDI is clinically non-inferior to Ipratropium+Salbutamol-CFC pMDI.
The safety profile of the two treatment groups was also similar.

P3593, presented at European Respiratory Society (ERS) Conference, 2007

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