Phase 3 COPD Trial, Completed NCT01040130 Sponsor: Boehringer Ingelheim 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 enrolled 151 people across six groups, each receiving different sequences of treatments — a placebo (inactive treatment), a 5 microgram dose of olodaterol (Olo 5 mcg), and a 10 microgram dose of olodaterol (Olo 10 mcg) — in varying orders over three treatment periods. The trial was designed as a "crossover" study, meaning every participant received all three treatments at different times, just in a different order. Between 20 and 25 people in each group completed the full study. The main thing being measured was how long participants could keep exercising on a stationary bike at a set level of effort after six weeks on each treatment. The reported data shows that after six weeks, the average exercise endurance time — measured in seconds — was approximately 370 seconds for the placebo group, around 422 seconds for those on the 5 mcg olodaterol dose, and around 421 seconds for those on the 10 mcg dose. For the secondary measures, the reported data shows that a lung capacity measurement called "inspiratory capacity" (how much air a person can breathe in) was slightly higher in both olodaterol groups compared to placebo, at several points during the exercise test. Breathing discomfort, rated on a scale of 0 (nothing at all) to 10 (maximum discomfort) during exercise, was reported as approximately 5.9 for placebo, 5.1 for the 5 mcg dose, and 5.2 for the 10 mcg dose. Before exercise began, discomfort scores were low across all groups (all under 0.3 out of 10). 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

NCT01040130
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 have agreed to take part by signing a consent form before the study begins.
  • You have been diagnosed with chronic obstructive pulmonary disease (COPD) and your breathing test results meet certain specific measurements (confirm with trial site).
  • You are between 40 and 75 years old (male or female).
  • You are a current or former smoker with at least a 10 pack-year smoking history (roughly, smoking one pack a day for 10 years, or equivalent).
  • You are able to do breathing tests, multiple exercise tests, and keep records as required by the study.
  • You are able to use an inhaler device correctly, including both a standard metered-dose inhaler and a Respimat inhaler.

Who may not be able to join:

  • You have significant abnormal results in blood or urine tests at the start of the study, including certain liver or kidney markers that are more than twice the normal level (confirm with trial site).
  • You have a history of asthma, or your blood shows a high level of a certain type of immune cell called eosinophils.
  • You have an overactive thyroid or a resting heart rate that is regularly above 100 beats per minute.
  • You have had a heart attack in the past year, a serious heart rhythm problem, a hospital stay for heart failure in the past year, active tuberculosis, certain cancers treated within the last five years, severe lung blockage, cystic fibrosis, significant bronchiectasis, serious alcohol or drug misuse, or a condition that makes exercise unsafe.
  • You have previously had surgery to remove part of a lung.
  • You are currently taking certain oral steroid or oral beta-adrenergic medications at unstable doses or at doses above a certain level (confirm with trial site).
  • You regularly use supplemental oxygen during the day for more than one hour per day.
  • You have completed a pulmonary rehabilitation programme in the six weeks before the study starts, or you are currently enrolled in one.
  • Your ability to exercise is limited by a reason other than tiredness or breathlessness during activity.
  • You are pregnant or currently breastfeeding.
  • You are a woman who could become pregnant and are not using two forms of birth control at the same time (one barrier method and one non-barrier method).

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 26 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.

Contact this trial

Principal Investigator: Boehringer Ingelheim, Boehringer Ingelheim

Australian sites

1222.37.6171 Boehringer Ingelheim Investigational Site, Daw Park, South Australia
1222.37.6174 Boehringer Ingelheim Investigational Site, Clayton, Victoria
1222.37.6173 Boehringer Ingelheim Investigational Site, Heidelberg, Victoria
1222.37.6172 Boehringer Ingelheim Investigational Site, Melbourne, Victoria

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

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 January 2010
Est. completion
1 April 2011

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany

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

Primary endpoints

Adjusted Mean Endurance Time After 6 Weeks

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: 26 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