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NCT00529529 · ClinicalTrials.gov registry record · Phase 3
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
A Phase 3 study of Asthma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 805
- Enrollment target
- 20
- Study locations
NCT00529529: Completed Phase 3 study of Asthma, sponsored by Novartis Pharmaceuticals.
NCT00529529 is a Phase 3 study of Asthma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 805 participants, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00529529, a Phase 3 study of Asthma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 805 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.
Primary Outcome
Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.
Conditions Studied
Interventions
- DRUG Indacaterol 300 μg
- DRUG Placebo to indacaterol
- DRUG Salmeterol 50 μg
- DRUG Placebo to salmeterol
Study Locations (20)
California
- Novartis Investigator Site - Encinitas
- Novartis Investigator Site - Huntington Beach
- Novartis Investigator Site - Long Beach
- Novartis Investigator Site - Long Beach
- Novartis Investigator Site - Los Angeles
- Novartis Investigator Site x 2 sites - Oakland
- Novartis Investigator Site - Orange
- Novartis Investigator Site - Palmdale
- Novartis Investigator Site - San Diego
- Novartis Investigator Site - San Diego
- Novartis Investigator Site - Walnut Creek
Colorado
- Novartis Investigator Site - Denver
- Novartis Investigator Site - Denver
- Novartis Investigator Site - Englewood
- Novartis Investigator Site - Lakewood
Florida
- Novartis Investigator Site - Brandon
- Novartis Investigator Site - Largo
- Novartis Investigator Site - Miami
Arizona
- Novartis Investigator Site - Glendale
- Novartis Investigator Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00529529 record still lists
NCT00529529 is an interventional study that assigns participants to a tested intervention. The registered 805 participants enrollment target is mid-sized for trials with a published cap, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Indacaterol 300 μg is the first listed.
NCT00529529 names 20 study sites across 4 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00529529 about?
NCT00529529 is a clinical study titled "Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma". This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.
What is the current status of trial NCT00529529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 805 participants. The study started on 2007-09. Estimated completion is 2008-08.
What conditions does trial NCT00529529 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT00529529?
The interventions under investigation include: Indacaterol 300 μg (DRUG), Placebo to indacaterol (DRUG), Salmeterol 50 μg (DRUG), Placebo to salmeterol (DRUG).
Who is sponsoring clinical trial NCT00529529?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00529529 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. 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 NCT00529529's enrollment target sits among peer trials
805 54th of 374 higher than 321 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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