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A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00622635 · View on ClinicalTrials.gov ↗
Study Summary
This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.
Conditions Studied
Interventions
- DRUG Indacaterol 300 μg
- DRUG Placebo to indacaterol
- DRUG Salmeterol 50 μg
Study Locations (14)
Other
- Novartis Investigator Site — Genk
- Novartis Investigator Site — Hasselt
- Novartis Investigator Site — Herentals
- Novartis Investigator Site — Alicante
- Novartis Investigator site — Alzira
- Novartis Investigator Site — Madrid
- Novartis Investigator site — Mataró
North Carolina
- Novartis Investigator Site — Charlotte
- Novartis Investigator Site — Raleigh
Illinois
- Novartis Investigator Site — Normal
Kansas
- Novartis Investigator Site — Shawnee Mission
Louisiana
- Novartis Investigator Site — Lafayette
Ohio
- Novartis Investigator site — Cincinnati
South Carolina
- Novartis Investigator Site — Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00622635
The ClinicalTrials.gov registry entry for NCT00622635 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 3 interventions — of which Indacaterol 300 μg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00622635 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, North Carolina, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00622635 about?
NCT00622635 is a clinical study titled "A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)". This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.
What is the current status of trial NCT00622635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2008-01. Estimated completion is 2008-07.
What conditions does trial NCT00622635 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00622635?
The interventions under investigation include: Indacaterol 300 μg (DRUG), Placebo to indacaterol (DRUG), Salmeterol 50 μg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00622635?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00622635 being conducted?
This trial has 14 study locations across Illinois, Kansas, Louisiana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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