Clinical Trial: Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients ≥ 6 Years of Age, Chronically Infected With

Brief Summary: The purpose of the study is to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung disease.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change in Lung Clearance Index [ Time Frame: Baseline, week 4 ]

The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. A LCI of 7.5 and below is normal,


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of FEV1 [ Time Frame: Baseline, week 4 ]
    Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry
  • Change of CFU [ Time Frame: Baseline, week 4 ]
    Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum.
  • Change of LCI [ Time Frame: Baseline, week 1 ]
    See Primary outcome measures
  • Change of LCI, FEV1 and CFU [ Time Frame: week 4, week 8 ]


Original Secondary Outcome:

  • Change of FEV1 [ Time Frame: Baseline, week 4 ]
    Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry
  • Change of CFU [ Time Frame: Baseline, week 4 ]
    Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gramm sputum.
  • Change of LCI [ Time Frame: Baseline, week 1 ]
    See Primary outcome measures
  • Change of LCI, FEV1 and CFU [ Time Frame: week 4, week 8 ]


Information By: Novartis

Dates:
Date Received: September 22, 2014
Date Started: January 27, 2015
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017