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NCT01836471 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
A Phase 2 study of Asthma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 345
- Enrollment target
- 20
- Study locations
NCT01836471: Completed Phase 2 study of Asthma, sponsored by Novartis Pharmaceuticals.
NCT01836471 is a Phase 2 study of Asthma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 345 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01836471, a Phase 2 study of Asthma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 345 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
Primary Outcome
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subj
Conditions Studied
Interventions
- DRUG QAW039
- DRUG Placebo QAW039
- DRUG Fluticasone 250 mcg
- DRUG Fluticasone 100 mcg
Study Locations (20)
California
- Novartis Investigative Site - Encinitas
- Novartis Investigative Site - Huntington Beach
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Mission Viejo
- Novartis Investigative Site - Orange
- Novartis Investigative Site - Palmdale
- Novartis Investigative Site - Riverside
- Novartis Investigative Site - Rolling Hills Estates
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - San Jose
- Novartis Investigative Site - Stockton
Colorado
- Novartis Investigative Site - Colorado Springs
- Novartis Investigative Site - Denver
- Novartis Investigative Site - Denver
Florida
- Novartis Investigative Site - Sarasota
Kentucky
- Novartis Investigative Site - Owensboro
Massachusetts
- Novartis Investigative Site - North Dartmouth
Minnesota
- Novartis Investigative Site - Minneapolis
Missouri
- Novartis Investigative Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01836471 record still lists
NCT01836471 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which QAW039 is the first listed.
NCT01836471 names 20 study sites across 7 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01836471 about?
NCT01836471 is a clinical study titled "A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients". The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.
What is the current status of trial NCT01836471?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 345 participants. The study started on 2013-05. Estimated completion is 2016-02.
What conditions does trial NCT01836471 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01836471?
The interventions under investigation include: QAW039 (DRUG), Placebo QAW039 (DRUG), Fluticasone 250 mcg (DRUG), Fluticasone 100 mcg (DRUG).
Who is sponsoring clinical trial NCT01836471?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01836471 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01836471's enrollment target sits among peer trials
345 107th of 374 higher than 267 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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