Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00622635 · ClinicalTrials.gov registry record · Phase 3
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
- 14
- Study locations
NCT00622635: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
NCT00622635 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 68 participants, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00622635, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
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 |
What the finished NCT00622635 record still lists
NCT00622635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (96% lower).
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.
NCT00622635 lists 14 locations in 7 states (Other, North Carolina, Illinois).
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.
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).
Who is sponsoring clinical trial NCT00622635?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
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 NCT00622635's enrollment target sits among peer trials
68 58th of 86 higher than 29 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
RECRUITING · Phase 3
-
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
RECRUITING · Phase 3
-
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
RECRUITING · Phase 3
-
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
ACTIVE NOT RECRUITING · Phase 3
-
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
COMPLETED · Phase 3
-
AMPLIFY - D6571C00001 Duaklir USA Phase III Study
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia