| Title |
Efficacy and safety of ipratropium bromide/salbutamol sulphate administered in a hydrofluoroalkane metered-dose inhaler for the treatment of COPD
|
|---|---|
| Published in |
International Journal of Chronic Obstructive Pulmonary Disease, June 2016
|
| DOI | 10.2147/copd.s89923 |
| Pubmed ID | |
| Authors |
Amal Bhattacharya, Salil Bhargava, Virendra Singh, Deepak Talwar, Jagdeep Whig, Juliet Rebello, Shrinivas Purandare, Jaideep Gogtay |
| Abstract |
The use of chlorofluorocarbons (CFCs) has contributed to the depletion of the stratospheric ozone layer resulting in serious health concerns. Ipratropium bromide/salbutamol sulphate CFC-pressurized metered-dose inhalers (IB/SAL-CFC pMDI) have been in widespread use for many years without any apparent ill consequences. This combination has now been reformulated using the hydrofluoroalkane (HFA) propellant. This study sought to establish the clinical noninferiority of a new HFA-containing IB/SAL pMDI to the conventional IB/SAL-CFC pMDI in subjects with mild/moderate COPD. This was a randomized, double-blind, parallel-group, multicenter study in two consecutive periods: a 14-day run-in period followed by a 85-day treatment period. Eligible mild-to-moderate stable COPD subjects aged 40-75 years were enrolled into the study and entered the run-in period during which subjects withdrew all the bronchodilators, except for salbutamol as rescue medication. Subjects were randomized to 85 days treatment with either IB/SAL-HFA or IB/SAL-CFC, 20 μg qid. Of the 290 randomized patients, 249 completed the study. The primary efficacy variable was the change in forced expiratory volume in one second from predose to 60 minutes after dosing on day 85. At the end of the treatment period, the adjusted mean change in forced expiratory volume in one second at 60 minutes was 123 mL in the IB/SAL-HFA pMDI group and 115 mL in the IB/SAL-CFC pMDI group. Because the lower limit of the 95% confidence interval for the between-group difference (-62 mL) was well within the noninferiority margin (-100 mL), the HFA formulation was deemed clinically noninferior to the CFC formulation. This finding was supported by secondary efficacy assessments. Both formulations of IB/SAL were well tolerated during the prolonged multiple dosing. It is concluded that IB/SAL-HFA pMDI provides effective bronchodilation of similar degree to that achieved with IB/SAL-CFC pMDI. Therefore, IB/SAL-HFA pMDI is a valuable alternative to IB/SAL-CFC pMDI. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 59 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 59 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 11 | 19% |
| Student > Master | 9 | 15% |
| Student > Bachelor | 8 | 14% |
| Other | 5 | 8% |
| Student > Ph. D. Student | 4 | 7% |
| Other | 7 | 12% |
| Unknown | 15 | 25% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 22% |
| Pharmacology, Toxicology and Pharmaceutical Science | 6 | 10% |
| Nursing and Health Professions | 5 | 8% |
| Unspecified | 3 | 5% |
| Agricultural and Biological Sciences | 3 | 5% |
| Other | 11 | 19% |
| Unknown | 18 | 31% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 July 2016.
All research outputs
#20,655,488
of 25,371,288 outputs
Outputs from International Journal of Chronic Obstructive Pulmonary Disease
#2,078
of 2,577 outputs
Outputs of similar age
#269,917
of 353,651 outputs
Outputs of similar age from International Journal of Chronic Obstructive Pulmonary Disease
#70
of 83 outputs
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