This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
Name: Ivacaftor
Description: Ivacaftor, 150 mg every 12 hours (q12h)Type: DrugSequence 1: First Ivacaftor Then Placebo Sequence 2: First Placebo Then Ivacaftor
Name: Placebo
Description: Placebo matched to IvacaftorType: DrugSequence 1: First Ivacaftor Then Placebo Sequence 2: First Placebo Then Ivacaftor
Description: LCI2.5; calculated as lung volume turnovers required to reach 2.5% of the starting nitrogen [N2] concentration
Measure: Change in lung clearance index 2.5 Time: from baseline through 8 weeksAllocation: Randomized
Crossover Assignment
There are 11 SNPs
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C→T or D1152H-CFTR Mutation. --- D1152H ---
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation. --- D1152H ---
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation. --- D1152H --- --- D1152H ---
- A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele. --- D1152H ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R --- --- R117H ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N ---
Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R ---