CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomized, double-blind, placebo-controlled pilot trial of megestrol acetate in malnourished children with cystic fibrosis.

Study design (if review, criteria of inclusion for studies)

RCT

Participants

35 children with CF (mean age 11.26 yrs; range 7-17; 19F) randomly selected into three groups.

Interventions

Group A of patients inhaling a beta-mimetic (salbutamol) before PT. Group B, patients inhaling placebo before PT. Group C, patients without any inhalations. In the first phase of the study, a bronchial reversibility test was done. On this ground we selected patients with bronchial hyperreactivity (BHR). In the second phase, each patient received PT.

Outcome measures

FEV1, FVC, FEV1/VC, MEF25, MEF50, MEF75, PEF before and after PT, and the weight of coughed-up sputum during PT

Main results

in 15 patients we observed BHR. In this group we found a statistically significant decrease in FEV1, FVC, MEF25% after PT. In patients without BHR we found a significant decrease in MEF25% only. The application of a bronchodilator before PT increased all studied parameters in both groups. In the case of FEV1, FVC, FEV1/VC, and PEF, the diferences were statistically significant in patients with BHR and only in PEF in the group without BHR. The largest quantity of sputum determined by its coughed-up weight was in patients with BHR inhaling beta-mimetic before PT

Authors' conclusions

PT increases bronchial obstruction in patients with BHR. 2. Bronchodilators increase the effectiveness of PT evaluated by coughed-up sputum weight in patients with BHR. 3. Bronchodilators do not increase effectiveness of PT in patients without BHR.

Keywords: Adolescent; Adrenergic beta-Agonists; Bronchodilator Agents; Child; Inhalation OR nebulised; non pharmacological intervention - devices OR physiotherapy; pharmacological_intervention; placebo; Salbutamol; Respiratory System Agents; Respiratory Tract Diseases;