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 enrolled 167 participants across four groups, who each rotated through three different treatment periods in a different order — a design sometimes called a "crossover" trial. The treatments being compared were two doses of indacaterol (150 micrograms and 300 micrograms), tiotropium (18 micrograms), and a placebo (dummy treatment with no active ingredient). The main thing the trial was measuring was lung function — specifically, how much air participants could forcefully breathe out in one second (called FEV1), tested roughly 24 hours after their last dose, following 14 days on each treatment. The reported data shows that after 14 days, the average FEV1 readings at the 24-hour mark were 1.53 litres for the indacaterol 150 μg group, 1.51 litres for the indacaterol 300 μg group, 1.48 litres for the tiotropium group, and 1.36 litres for the placebo group. The trial also measured peak lung function in the first four hours after the very first dose on Day 1. The reported data shows those peak FEV1 readings were 1.65 litres for indacaterol 150 μg, 1.67 litres for indacaterol 300 μg, 1.62 litres for tiotropium, and 1.48 litres for placebo. Not all participants who started the trial completed every period, though most did. 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 20920365) ↗
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 are a man or woman aged 40 or older who is willing to sign a consent form before any study activities begin
- You have been diagnosed with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term lung condition that makes it hard to breathe
- You have a smoking history of at least 10 "pack years" — meaning, for example, smoking one pack a day for 10 years (current or past smokers both count)
- Your breathing test results after using a bronchodilator (a medicine that opens the airways) fall within a specific range showing reduced lung function (confirm with trial site for exact numbers)
- You are able to attend appointments as an outpatient (no overnight hospital stays required for the study itself)
Who may not be able to join:
- You were hospitalised due to a COPD flare-up in the 6 weeks before the first visit, or during the early part of the study
- You need to use oxygen at home regularly because your blood oxygen levels are consistently low
- You have had a chest or respiratory infection in the 6 weeks before your first visit
- You have another lung condition alongside COPD
- You have a history of asthma
- You have Type 1 diabetes, or Type 2 diabetes that is not well controlled
- You have lung cancer now or have had it in the past
- You currently have cancer, or have had cancer in the past and have not been cancer-free for at least 5 years
- You have a history of a heart rhythm condition called long QT syndrome, or a related abnormality was found on your heart tracing (ECG) at your first visit (confirm with trial site)
- You received a live vaccine (such as certain flu or travel vaccines) within 30 days before the study screening or during the early part of the study
- You are unable to use an inhaler device correctly or unable to complete breathing tests
Important: 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 Pharma, 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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.