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Drug & research development » Clinical trials » NCT01937325

Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX-770 (Ivacaftor) (CPET in CF)

Official title: Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX-770 (Ivacaftor)

Clinical Trials gov number: NCT01937325

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Purpose: To examine correlates between improvements in lung function, exercise capacity, inflammatory markers and indices of wellbeing in CF patients with ≥1 G551D mutation taking ivacaftor.

Phase: 4

Type: Interventional, randomized, double-blind, crossover assignment

Study sponsor: The Alfred

  • CF proven based on established criteria (sweat test, genotype and phenotype)
  • At least one copy of the G551D mutation
  • Able to perform an exercise study and complete study questionnaires and assessments
  • Lung function inclusion above 25% predicted FEV1

Intervention
Ivacaftor

Geographical Location
No contacts or locations provided

Number of Participants
≤50 (16-70 years)

Primary Endpoint

Exercise capacity over 28 days, repeated for each arm

Respiratory exercise testing, including spirometry and V02 max

Secondary Endpoint

  • Inflammatory profile over 28 days, repeated for each arm

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  • Active Comparator:

    Ivacaftor 150mg orally twice daily

  • Placebo Comparator:

      Matching placebo

Subjects will be randomly assigned to initial active treatment or placebo following a 4-week run-in period. After completion of period 1 and a 4-week washout period, subjects will cross-over to the alternative treatment. After 4 weeks of period 2, subjects will undergo final assessment

View Trial Results