CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
primary studies published RCT

Effects of montelukast treatment on clinical and inflammatory variables in patients with cystic fibrosis.

  • Year: 2005
  • Date: 2008
  • Author: Stelmach I
Source

Ann Allergy Asthma Immunol. 2005 Oct;95(4):372-80.

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

randomised double-blind, placebo-controlled trial

Participants

Thirty-eight patients (21 AZM/17 placebo) (mean age: 23.7 years; mean FEV(1): 62% of predicted) were recruited.

Interventions

patients received AZM or placebo 1 per week for 8 weeks (AZM dosage--20-29 kg: 500 mg, 30-39 kg: 750 mg, 40-49 kg: 1000 mg and > or = 50 kg: 1250 mg) after a course of intravenous antipseudomonal antibiotics.

Outcome measures

Pulmonary function tests, the serum markers LPS-binding protein (LBP), interleukin-8 (IL-8), CRP, P. aeruginosa alginate in sputum samples and quality of life scores were evaluated.

Main results

After treatment (mean dose of 21.2 mg/kg body weight once a week) pulmonary function declined in both groups compared to baseline (i.e. after cessation of i.v. antibiotics). The AZM group was significantly better for mean changes in serum CRP (AZM: +0.9 mg/l, placebo: +21.6 mg/l, p=0.019), lipopolysaccharide binding protein in serum, LBP (AZM: +0.9 microg/ml, placebo: +7.0 microg/ml, p=0.015), serum interleukin-8 (AZM: -3.1 pg/ml, placebo: +2.9 pg/ml, p=0.001) and alginate in sputum (AZM: +85 microg/ml, placebo: +353 microg/ml, p=0.048). Quality of life was significantly better after AZM and there was no increase in treatment-related adverse events.

Authors' conclusions

Once-weekly azithromycin ameliorated inflammatory reactions and improved quality of life. A decline of pulmonary function after cessation of i.v. antibiotics could not be prevented.

Keywords: Adult; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Drug Administration Schedule; Infection; pharmacological_intervention; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Intravenous; Macrolides; Anti-Inflammatory Agents; Anti-Inflammatory Agents - excl Steroids;