CFDB - Cystic Fibrosis DataBase

primary studies published RCT

The effects of the inhaled corticosteroid budesonide on lung function and bronchial hyperresponsiveness in adult patients with cystic fibrosis.

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

Randomised 4-way cross-over design

Participants

Mean age = 22.1 years, range 19 years to 28 years (SD 3.8 years) n = 10 Males = 7 Females = 3. FEV1 % predicted 52.0% SD 6.7 range 31 to 84%

Interventions

HS 12% single dose (treatment group 3) Pre-treated with nebulised salbutamol 5 mg HS 3% single dose (treatment group 1) HS 7% single dose (treatment group 2) Voluntary cough and IS combined as the control Each participant took part in each arm

Outcome measures

Sputum isotope % clearance at 30 minutes Sputum isotope clearance at 90 minutes* Mucociliary clearance*

Main results

Neither mannitol nor HS improved BMC during the actual intervention period compared with their respective controls. However during the post-intervention measurement there was a significant improvement in BMC for both the mannitol (8.7+/-3.3% versus 2.8+/-0.7%) and HS (10.0+/-2.3% versus 3.5+/-0.8%). There was also a significant improvement in cough clearance with the Mannitol (9.7+/-2.4%) compared with its control (2.5+/-0.8%). Despite premedication with a bronchodilator, a small fall in forced expiratory volume in one second (FEV1) was seen immediately after administration of both the mannitol (7.3+/-2.5%) and HS (5.8+/-1.2%). Values of FEV1 returned to baseline by the end of the study.

Authors' conclusions

Inhaled mannitol is a potential mucoactive agent in cystic fibrosis patients. Further studies are required to establish the optimal dose and the long-term effectiveness of mannitol.

Keywords: Adolescent; Adult; hydration; Hypertonic Solutions; Inhalation OR nebulised; Mannitol; pharmacological_intervention; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Respiratory System Agents;