Phase 3 COPD Trial, Completed NCT00792805 Sponsor: Novartis Pharmaceuticals Condition: COPD
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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 looked at a medicine called indacaterol (tested at two different doses — 150 micrograms and 300 micrograms) compared to a placebo (a dummy treatment with no active ingredient) in people with a lung condition. A total of 563 people were enrolled across the three groups — roughly 188 in each — and the trial ran for 12 weeks. The main thing being measured was lung function, specifically how much air participants could forcefully breathe out in one second (known as FEV1). This measurement was taken about 23–24 hours after the last dose, to see how well the medicine's effect lasted overnight. The reported data shows that at the end of the 12-week treatment period, the average FEV1 reading was 1.32 litres in the 150 microgram indacaterol group, 1.29 litres in the 300 microgram indacaterol group, and 1.17 litres in the placebo group. These numbers represent averages across participants in each group at that single time point. It is worth noting that the trial did not report completing data for all participants who started — 166, 162, and 154 people finished in each group respectively, meaning some participants left the trial early. No secondary outcome measure data was included in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT00792805
Completed Phase 3 🇦🇺 Australian site

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 40 years of age or older
  • 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" (for example, smoking one pack per day for 10 years, or two packs per day for 5 years)
  • Your lung function test results after using a bronchodilator (a medicine that opens the airways) fall within a specific range showing reduced lung capacity (confirm with trial site)

Who may not be able to join:

  • You have taken steroid tablets or injections for a COPD flare-up in the 6 weeks before screening or during the run-in period
  • You need to use oxygen for more than 15 hours a day due to low oxygen levels in your blood
  • You have had a chest or breathing infection in the 6 weeks before screening
  • You have another lung or breathing 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 or have had it in the past
  • You have or have had any other type of cancer 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 screening
  • You have received a live vaccine (such as for flu or chickenpox) within 30 days before screening or during the run-in period
  • You are unable to use a dry powder inhaler device or complete breathing tests (spirometry)

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 November 2008
Est. completion
1 February 2010

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇮🇳 India

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov