Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01513460) enrolled 773 adults across three treatment groups: one group received NVA237 (a type of inhaled bronchodilator) combined with fluticasone/salmeterol (a common inhaled combination preventer, referred to as Flu/Sal); a second group received tiotropium (another bronchodilator) combined with Flu/Sal; and a third group received Flu/Sal alone. The trial was primarily measuring changes in lung airflow — specifically a breathing test called FEV1 (how much air a person can forcefully breathe out in one second) — at a set point near the end of a dosing cycle, known as "trough" FEV1. The study ran for 12 weeks and also looked at quality-of-life scores, use of reliever ("rescue") medication, and nighttime awakenings due to symptoms. The reported data shows that, for the primary outcome comparing NVA237 + Flu/Sal against tiotropium + Flu/Sal, both groups showed a small increase in trough FEV1 from their starting point — an average change of +0.095 litres in the NVA237 + Flu/Sal group and +0.102 litres in the tiotropium + Flu/Sal group. For the secondary outcomes comparing these two combined groups against Flu/Sal alone, the reported data shows the Flu/Sal-only group had a very small decrease from baseline (around −0.010 to −0.012 litres depending on the time point), while the two combined groups showed increases in the range of +0.077 to +0.092 litres. On the quality-of-life questionnaire (scored 0–100, where lower is better), scores changed by −2.8, −3.9, and −0.7 points for the NVA237 + Flu/Sal, tiotropium + Flu/Sal, and Flu/Sal-only groups respectively. The reported data also shows average daily rescue inhaler use of approximately 2.2, 2.1, and 2.9 puffs per day across the three groups, and the percentage of nights without symptom-related awakenings was reported as roughly 83%, 82%, and 82% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 25841237) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 COPD Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with moderate to severe COPD (classified as Stage II or Stage III under standard medical guidelines)
- You are a current smoker or ex-smoker with a smoking history of at least 10 "pack years" (for example, smoking one pack a day for 10 years, or two packs a day for 5 years)
- You meet a specific lung function test result (called an FEV1 measurement) taken at a particular visit before the trial begins (confirm with trial site)
Who may not be able to join:
- You have a history of asthma, or have previously had a high level of certain white blood cells (eosinophils) in your blood
- You have another lung or breathing condition alongside your COPD
- You have previously had surgery to remove part of a lung, surgery to reduce lung size, or a lung transplant
- You have a genetic condition called alpha-1 antitrypsin deficiency, which can cause lung problems
- You have received a "live" vaccine (such as certain flu or travel vaccines) within 30 days before the start of the trial or during the early run-in phase of the trial
Important: There may be additional criteria not listed here. Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
58 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.