Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
Completed · Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.
Key facts
- Study ID
- NCT01685801
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 24
- Starts
- 2012-09-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-05-19
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female participants with confirmed diagnosis of CF
- Clinical evidence of residual CFTR function based on any 1 of the following: 1) Clinically documented residual exocrine pancreatic function, 2) Sweat chloride value less than equal to (<=) 80 millimole per liter (mmol/L) at screening, or 3) Age of diagnosis greater than equal to (>=) 12 years and at least 1 copy of a CFTR mutation associated with residual CFTR function or defective mRNA splicing
- FEV1 >= 40 percent (%)
- 12 years of age or older
- Willing to agree to meet the contraception requirements
- Able to swallow tablets
You may not qualify if…
- A copy of any of the following CFTR mutations: G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, or G1349D
- Unable to perform spirometry
- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
- Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
Where it is running
- Study site — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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