Phase 2 Cystic Fibrosis Trial, Completed NCT00737100 Sponsor: Boehringer Ingelheim Condition: Cystic Fibrosis
Back to Cystic Fibrosis

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 510 people across three groups: 168 received a placebo (dummy treatment), 166 received a lower dose of tiotropium Respimat (2.5 micrograms), and 176 received a higher dose (5 micrograms). The vast majority of participants finished the trial — around 161, 159, and 169 people respectively in each group. The trial was measuring changes in lung function over 12 weeks, specifically looking at how well participants could breathe out air, using several different breathing tests. The reported data shows the following numbers for the two main measures at week 12. For the first primary measure — how much air participants could forcefully breathe out over one second, averaged across a four-hour window — the placebo group's score changed by −1.74 percentage points from their starting point, while the 2.5 microgram group changed by +1.20 and the 5 microgram group by +1.65 percentage points. For the second primary measure — the same breathing-out test but taken at a single "trough" point (the lowest point before the next dose) — the placebo group changed by −1.44 percentage points, compared with +0.81 for the 2.5 microgram group and +0.78 for the 5 microgram group. The reported data also shows results from several secondary (additional) lung function measures at week 12. For the total amount of air breathed out in one breath (FVC), averaged across four hours, changes were −1.30 for placebo, +0.53 for the lower dose, and +1.81 percentage points for the higher dose. A measure of airflow through the middle part of a breath showed changes of −1.40, +2.78, and +3.94 percentage points respectively. A measure of air trapped in the lungs (RV/TLC ratio) showed very small changes of −0.01, 0.00, and +0.04 percentage points across the three groups. 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 2 Cystic Fibrosis Trial, Completed

NCT00737100
Completed Phase 2 🇦🇺 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:

  • Both men and women can apply.
  • You must have a confirmed diagnosis of Cystic Fibrosis, shown either by a sweat chloride test or by having two identified genetic mutations related to CF.
  • Your lung function (measured by a breathing test called FEV1) must be at least 25% of the normal expected value, measured before using an inhaler.

Who may not be able to join:

  • You may not be eligible if you have a significant history of allergies or serious allergic reactions.
  • You may not be eligible if you are known to be allergic or sensitive to the medication being studied.
  • You may not be eligible if you are currently taking part in another clinical trial.
  • Women who are pregnant or breastfeeding may not be eligible.
  • Women who are able to become pregnant may not be eligible (confirm with trial site).
  • You may not be eligible if you have started a new medication for Cystic Fibrosis within the 4 weeks before your screening appointment.
  • You may not be eligible if you have a known history of substance misuse or abuse.
  • You may not be eligible if you have another serious medical condition beyond Cystic Fibrosis.

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 27 July 2026
Phase 2: approximately ~30% 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

205.339.100 Boehringer Ingelheim Investigational Site, Westmead, New South Wales
205.339.101 Boehringer Ingelheim Investigational Site, Westmead, New South Wales
205.339.103 Boehringer Ingelheim Investigational Site, Adelaide, South Australia
205.339.104 Boehringer Ingelheim Investigational Site, Subiaco, Western Australia

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 2
Registry
ClinicalTrials.gov
Start date
1 September 2008
Est. completion
1 April 2010

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇹 Portugal 🇷🇺 Russia 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percent Predicted FEV1 AUC0-4 Response at the End of Week 12; Percent Predicted FEV1 Trough Response at the End of Week 12

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: 27 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