An evaluation of salmeterol in the treatment of chronic obstructive pulmonary diseases.
BACKGROUND
Salmeterol has been shown a useful drug for the treatment of chronic obstructive pulmonary disease (COPD). However, its positioning in the current treatment of COPD remains to be defined. The present study was carried out to evaluate its role as an add-on drug to the current first-line drug, ipratropium.


METHODS
A double-blind randomized, parallel group, placebo-controlled design was used in an outpatient setting. Thirty-three patients with moderate or severe COPD were included. After a run-in period of two weeks on 40 microg four-times-daily ipratropium and 400 microg twice-daily beclomethasone dipropionate, they were randomized into two groups to receive either salmeterol (50 microg twice daily) or placebo for eight weeks. The outcome parameters were: (i) spirometry, (ii) six-minute walking test, (iii) SF-36 health-related quality of life (HRQoL) questionnaire score, (iv) baseline dyspnoea index (BDI), (v) patient's self-assessment and (vi) supplemental use of salbutamol.


RESULTS
The mean FEV1 and FVC increased significantly over the initial values in the salmeterol group but not in the placebo group. Salmeterol produced greater improvements in almost all the dimensions of HRQoL as well as in the BDI and the supplemental use of salbutamol was lower in this group. However, the six-minute walk distance was similar in the two groups.


CONCLUSIONS
The present study shows that eight weeks treatment with salmeterol 50 microg twice-daily added to the existing regimen of ipratropium bromide and beclomethasone dipropionate provides greater symptomatic relief and improvement in lung function than placebo. This is accompanied by an improvement in the health-related quality of life.
Department of Cardiorespiratory Physiology, Vallabhbhai Patel Chest Institute, University of Delhi.
Rakesh K
RK
Gupta
Sunil K
SK
Chhabra
D000328:Adult; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001507:Beclomethasone / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000534:rehabilitation; D011788:Quality of Life; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D009241:Ipratropium; D001507:Beclomethasone; D000420:Albuterol