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NCT01120691 · ClinicalTrials.gov registry record · Phase 3

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
2,224
Enrollment target

NCT01120691: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT01120691 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 2,224 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01120691, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
2,224 participants
Enrollment target

Study Summary

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

Primary Outcome

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of modera

Interventions

  • DRUG tiotropium
  • DRUG NVA237
  • DRUG QVA149
  • DRUG Salbutamol/albuterol

Trial Details

FieldValue
Enrollment Target 2,224 participants
Start Date 2010-04
Est. Completion 2012-07
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01120691 record still lists

NCT01120691 is an interventional study that assigns participants to a tested intervention. Its 2,224 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (188% higher).

The record links to 0 conditions, and to 4 interventions - of which tiotropium is the first listed.

NCT01120691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01120691 about?

NCT01120691 is a clinical study titled "Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations". This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

What is the current status of trial NCT01120691?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,224 participants. The study started on 2010-04. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01120691?

The interventions under investigation include: tiotropium (DRUG), NVA237 (DRUG), QVA149 (DRUG), Salbutamol/albuterol (DRUG).

Who is sponsoring clinical trial NCT01120691?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01120691's enrollment target sits among peer trials

2,224 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT01120691, the US trial registry maintained by the National Library of Medicine. NCT01120691 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.