Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
NCT ID: NCT02566044
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2017-09-27
2018-04-24
Brief Summary
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The study was terminated after Cohort 2 due to the resource issues.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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CQBW276
Cohorts 1 and 2 will enroll 8 patients each (6:2 QBW276 and placebo, respectively).
Cohort 1: dose is 3 mg bid (6 mg daily) QBW276 or placebo for 7 days. Cohort 2: dose and frequency will be confirmed after cohort 1 is complete. The duration is 14 days.
Cohort 3: dose and frequency will be confirmed after cohort 2 is complete. The duration is approximately 4 months. Patients will be randomized to one of two treatment sequences: QBW276 in Period 1 and Placebo in Period 2 or Placebo in Period 1 and QBW276 in Period 2. Twenty four patients are required to complete cohort 3.
QBW276
0.3 mg and 1.5 mg strengths
Placebo
Cohorts 1 and 2 will enroll 8 patients each (6:2 QBW276 and placebo, respectively).
Cohort 1: dose is 3 mg bid (6 mg daily) QBW276 or placebo for 7 days. Cohort 2: dose and frequency will be confirmed after cohort 1 is complete. The duration is 14 days.
Cohort 3: dose and frequency will be confirmed after cohort 2 is complete. The duration is approximately 4 months. Patients will be randomized to one of two treatment sequences: QBW276 in Period 1 and Placebo in Period 2 or Placebo in Period 1 and QBW276 in Period 2. Twenty four patients are required to complete cohort 3.
Placebo
Placebo
Interventions
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Placebo
Placebo
QBW276
0.3 mg and 1.5 mg strengths
Eligibility Criteria
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Inclusion Criteria
* Cohort 3 = F508del homozygotes on standard of care at that time
* FEV₁between 40 and 100%
* LCI2.5 ≥ 8 if FEV₁is more than 80%
Exclusion Criteria
* Lung transplant
* Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Essen, , Germany
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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2014-004915-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQBW276X2201
Identifier Type: -
Identifier Source: org_study_id