Bronchodilatory effects of salbutamol, ipratropium bromide, and their combination: double-blind, placebo-controlled crossover study in cystic fibrosis.
Study design (if review, criteria of inclusion for studies)
Dual intervention cross-over trial over 4 days
Participants
17 participants (6 males), age range 7 - 33 years, 16 participants analysed
Interventions
Randomised to single dose nebulised placebo, salbutamol 5 mg, ipratropium 0.25 mg or combination
Outcome measures
Changes in spirometry (FVC, FEV1, FEF25-75, FEF50, TGV, Raw ) measured at baseline and 30 minutes later
Main results
The mean forced expiratory volume in the first second improved significantly (adjusted P-value < 0.017) after each treatment compared to placebo. Analysis of variance showed that SB and combination therapy with SB and IB were superior to IB alone, without significant difference between SB and combination therapy. Response of a patient to combined therapy was usually associated with response to SB. Long-term efficacy and side effects of treatment with bronchodilators still remain to be investigated after this short term study.
Authors' conclusions
in CF patients bronchodilator therapy with sympathomimetic agents is usually sufficient. Only in cases with proven additional benefit from inhalation by anticholinergics should combination therapy be recommended.