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primary studies published RCT

The effect of treatment with ursodeoxycholic acid in cystic fibrosis and hepatopathy: results of a placebo-controlled study.

  • Year: 1991
  • Date: 1996
  • Author: Bittner P
Source

Bile acids as therapeutic agents. From basic science to clinical practice. Falk symposium 58. YR: 1991 DE: RCT

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

Randomised cross-over trial

Participants

Mean age 16.5 years, range 13 years to 20 years n = 10 Males = 3, females = 7 Participants were recruited as they were admitted with exacerbations of their lung disease with cough productive of tenacious sputum Severity of lung disease; median FEV1 as % predicted 72, median FVC % predicted 53.5

Interventions

Cross-over to IS daily for 2 days (control group) Pre-treated with nebulised salbutamol 5 mg HS 6% daily for 2 days (treatment group)

Outcome measures

Sputum weight VAS, feeling of cleared chest

Main results

The percent cleared at 60 and 90 min was significantly increased with HS (%C60 = 26.5%, %C90 = 29.4%) and the combination of AML + HS (%C60 = 23.1%, %C90 = 27.4%) compared with both IS (%C60 = 14.7%, %C90 = 17.5%) and COUGH (%C60 = 18.0%, %C90 = 19.5%), p < 0.01. Inhalation of hypertonic saline is a potentially useful treatment in patients with cystic fibrosis.

Keywords: Amiloride; hydration; Hypertonic Solutions; pharmacological_intervention; Airway clearance drugs -expectorants- mucolytic- mucociliary-; ENaC antagonists - Sodium Channel Blockers; Respiratory System Agents;