Triple inhaler shows promise for COPD sufferers
NCT ID NCT01917331
First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This phase 3 trial tested a new triple-combination inhaler (beclometasone, formoterol, and glycopyrrolate) against a standard two-drug inhaler in 1,368 adults with severe COPD. The study measured changes in lung function and breathlessness over 52 weeks. The goal was to see if the triple therapy provides better symptom control and fewer flare-ups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Beclometasone, formoterol, and glycopyrrolate (triple-combination inhaler)
- What this could lead to
- If successful, this triple inhaler could offer better lung function and symptom control for people with severe COPD compared to current two-drug inhalers.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all COPD patients. The triple inhaler may cause more side effects (e.g., throat irritation, pneumonia) and may not improve quality of life for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
1,368 people
The number who actually took part.
- Started
-
Mar 2014
- Finished
-
Jan 2016
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female adults aged ≥ 40 years with a diagnosis of COPD * Current smokers or ex-smokers * A post-bronchodilator Forced Expiratory Volume in the 1st Second (FEV1) \< 50% of the predicted normal value and a post- bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.7 * At least one exacerbation in the 12 months preceding the screening visit Exclusion Criteria: * Pregnant or lactating women * Diagnosis of asthma or history of allergic rhinitis or atopy * Patients treated with non-cardioselective β-blockers in the month preceding the screening visit * Patients treated for exacerbations in the 4 weeks prior to screening visit * Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN * Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia * Known respiratory disorders other than COPD * Patients who have clinically significant cardiovascular condition
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dr Beatrix BALINT
Szeged, 6722, Hungary
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