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Mucociliary Clearance Completed with Results
Study of QBW276 in adults with CF (Novartis CQBW276X2201)
This study evaluated the safety and tolerability of QBW276, an inhaled drug designed to improve mucus clearance. This study also evaluated how the body processes the drug.
This study was placebo-controlled, which means that some participants received inhaled QBW276, and some participants received placebo. Study participants were split into two groups. Participants in Group 1 were randomly assigned to receive either QBW276 (3 mg once a day) or placebo for 7 days. Participants in Group 2 were randomly assigned to receive either QBW276 (6 mg once a day) or placebo for 14 days.
Eligibility
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Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
This study found that at doses of 3mg and 6mg, QBW276 was generally well-tolerated. However, 67% of participants in Group 2 experienced increased cough. This study was terminated after completion of all participants in Group 2 due to strategic issues.
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Primary Findings:
Effectiveness:
Safety:
This study was conducted between September 2017 and September 2018. The study enrolled 16 participants (Group 1 N=6, Group 2 N=6, Placebo N=4).
The primary objective of the study was safety. Safety was determined by tracking adverse events that occurred during treatment. Overall, QBW276 was well-tolerated. However, 67% (4/6) of participants in Group 2 experienced increased cough.
The study was terminated after completion of all randomly assigned participants in Group 2 due to strategic issues. These results have been provided by Clinicaltrials.gov and have not been peer-reviewed.
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Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
14 days -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Novartis -
Study Drugs:
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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