Pulmonary Disease, Chronic ObstructivePhase 4NCT03081156
The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, run by William Stringer, md at 1 site in United States.
Trial summary
The objective of the study is to determine if a dual inhaled bronchodilator (Glycopyrrolate/Formoterol) is effective in increasing exercise time relative to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have a clinical diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria:
- Stable state of their disease with no exacerbation (antibiotics, oral steroids, ER visit, or hospitalization for COPD) within the previous 4 weeks; and
- At visit 1 Spirometric Values must demonstrate a post-bronchodilator FEV1 between 35% and 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%. [The rationale for the lower limit is to exclude patients unlikely to tolerate withholding of long acting bronchodilators. The rationale for the upper limit is to exclude patients unlikely to be limited in their exercise tolerance by hyperinflation and air trapping.]
- Male or female patients, between 40 and 80 years (inclusive) of age.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
- Patients must be able to perform technically acceptable pulmonary function tests and a symptom-limited cardiopulmonary cycle ergometry test.
- Patients must be able to inhale medication in an acceptable manner from the metered dose inhalers used in this study.
Who cannot join
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
- Patients with a documented personal history of childhood asthma, a clinical presentation consistent with asthma, and a family history of asthma. For patients with allergic rhinitis, atopy, or prior allergy treatment, medical records will be obtained to verify that the patient does not have asthma. The final determination on the possibility of an overlap condition [Asthma-COPD Overlap Syndrome, (Postma and Rabe, 2015)], and thus, appropriateness for entry into the study, will be the principal investigator's decision.
- Patients with any of the following conditions:
- A history of myocardial infarction within 1 year of screening visit.
- Unstable or life-threatening cardiac arrhythmia.
- Hospitalized for heart failure within the past year.
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- Known active tuberculosis.
- A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the past 6 months (patients with treated local skin tumors are allowed).
- A history of life-threatening COPD exacerbation requiring intubation.
- A history of cystic fibrosis.
- Clinically significant and active bronchiectasis.
- A history of alcohol or drug abuse within the past year.
- Any contraindications for exercise testing as outlined below (see contraindications to exercise).
- Patients who have undergone thoracotomy with pulmonary resection in the past year.
- Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Patients who regularly use daytime oxygen therapy for more than 6 hours per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits and exercise testing.
- Patients who desaturate to SpO2 <80% on screening incremental exercise testing.
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
- Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
- Patients with a constant power cycle ergometry endurance time less than 4 or greater than 8 minutes after work rate adjustment procedures (described below).
- Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to screening visit (Visit 1).
- Pregnant or nursing women.
- Women of childbearing potential who are not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Patients who are currently participating in another interventional study.
- Patients who are unable to comply with pulmonary medication restrictions (washout of any LABA/LAMA) prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: An Investigator Initiated, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of Glycopyrrolate/Formoterol on Exercise Tolerance and Dynamic Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease.
The objective of the study is to determine if a dual inhaled bronchodilator (Glycopyrrolate/Formoterol) is effective in increasing exercise time relative to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
Enrolled patients with COPD will be randomized to receive either a dual bronchodilator (Glycopyrrolate/Formoterol) or placebo inhaler, and then crossed over to receive the opposite intervention. The study will consist of two treatment periods of two weeks, seperated by a washout period of two weeks.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler
- Keywords
- chronic obstructive pulmonary disease (COPD), exercise intolerance, dynamic hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrrolate / Formoterol Inhaler vs Placebo InhalerDrug
Also called Bevespi AEROSPHERE
Exercise Tolerance
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate/Formoterol Inhaler then Placebo Inhaler | Active comparator | Participants receive the Glycopyrrolate/Formoterol inhaler for a two week period. After a two week washout, the participants then received a placebo Glycopyrrolate/Formeterol inhaler for two weeks. Receives: Drug: Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler |
| Placebo Inhaler then Glycopyrrolate/Formeterol Inhaler | Placebo comparator | Treatment for 2 weeks with a placebo Glycopyrrolate/Formoterol inhaler. After a two week washout, the participant then received two weeks of the Glycopyrrolate/Formoterol inhaler. Receives: Drug: Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise.
To determine the magnitude of exercise time improvement (seconds) with BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) relative to placebo during high intensity, constant work rate cycle ergometer exercise in COPD patients.
Measured: 8-12 weeks
Secondary outcomes (1)
VD/VT as Determined by Transcutaneous CO2 Measurement (tcpCO2) During Constant Work Rate Cycle Ergometer Exercise.
To determine if the VD/VT can be reliably assessed during constant work rate exercise using transcutaneous CO2 measurement (tcpCO2) and, if so, if BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) results in a reduction in VD/VT relative to placebo at isotime during high intensity constant work rate exercise in COPD patients.
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start27 Mar 2017
- Primary completion1 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double Blind, Cross-Over Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Stringer, md
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William Stringer, md, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- William W Stringer, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081156
- Sponsor's protocol ID
- 21752-01
- Status last verified
- Oct 2025
- First submitted
- 9 Mar 2017
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stringer WW, Porszasz J, Cao M, Rossiter HB, Siddiqui S, Rennard S, Casaburi R. The effect of long-acting dual bronchodilator therapy on exercise tolerance, dynamic hyperinflation, and dead space during constant work rate exercise in COPD. J Appl Physiol (1985). 2021 Jun 1;130(6):2009-2018. doi: 10.1152/japplphysiol.00774.2020. Epub 2021 Apr 29.
PubMed 33914661
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of Glycopyrrolate/Formoterol on Exercise Tolerance and Dynamic Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT03081156
- Acronym / sponsor ID
- 21752-01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- chronic obstructive pulmonary disease (COPD), exercise intolerance, dynamic hyperinflation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- William Stringer, mdUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine if a dual inhaled bronchodilator (Glycopyrrolate/Formoterol) is effective in increasing exercise time relative to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
Enrolled patients with COPD will be randomized to receive either a dual bronchodilator (Glycopyrrolate/Formoterol) or placebo inhaler, and then crossed over to receive the opposite intervention. The study will consist of two treatment periods of two weeks, seperated by a washout period of two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Cross-Over Study
| Arm | Type | Receives |
|---|---|---|
| Glycopyrrolate/Formoterol Inhaler then Placebo Inhaler | Active comparator | Drug: Glycopyrrolate / Formoterol Inhaler vs Placebo InhalerParticipants receive the Glycopyrrolate/Formoterol inhaler for a two week period. After a two week washout, the participants then received a placebo Glycopyrrolate/Formeterol inhaler for two weeks. |
| Placebo Inhaler then Glycopyrrolate/Formeterol Inhaler | Placebo comparator | Drug: Glycopyrrolate / Formoterol Inhaler vs Placebo InhalerTreatment for 2 weeks with a placebo Glycopyrrolate/Formoterol inhaler. After a two week washout, the participant then received two weeks of the Glycopyrrolate/Formoterol inhaler. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients must have a clinical diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria:
- Male or female patients, between 40 and 80 years (inclusive) of age.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
- Patients must be able to perform technically acceptable pulmonary function tests and a symptom-limited cardiopulmonary cycle ergometry test.
- Patients must be able to inhale medication in an acceptable manner from the metered dose inhalers used in this study.
Key exclusion criteria (25 listed)
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
- Patients with a documented personal history of childhood asthma, a clinical presentation consistent with asthma, and a family history of asthma. For patients with allergic rhinitis, atopy, or prior allergy treatment, medical records will be obtained to verify that the patient does not have asthma. The final determination on the possibility of an overlap condition [Asthma-COPD Overlap Syndrome, (Postma and Rabe, 2015)], and thus, appropriateness for entry into the study, will be the principal investigator's decision.
- Patients with any of the following conditions:
- Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Patients who regularly use daytime oxygen therapy for more than 6 hours per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits and exercise testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycopyrrolate / Formoterol Inhaler vs Placebo InhalerAlso: Bevespi AEROSPHEREExercise Tolerance | Drug | Glycopyrrolate/Formoterol Inhaler then Placebo Inhaler, Placebo Inhaler then Glycopyrrolate/Formeterol Inhaler |
Primary outcome
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise.
Time frame: 8-12 weeks
To determine the magnitude of exercise time improvement (seconds) with BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) relative to placebo during high intensity, constant work rate cycle ergometer exercise in COPD patients.
1 secondary outcome
VD/VT as Determined by Transcutaneous CO2 Measurement (tcpCO2) During Constant Work Rate Cycle Ergometer Exercise.
Time frame: 8 to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33914661Stringer WW, Porszasz J, Cao M, Rossiter HB, Siddiqui S, Rennard S, Casaburi R. The effect of long-acting dual bronchodilator therapy on exercise tolerance, dynamic hyperinflation, and dead space during constant work rate exercise in COPD. J Appl Physiol (1985). 2021 Jun 1;130(6):2009-2018. doi: 10.1152/japplphysiol.00774.2020. Epub 2021 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Stringer, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, run by William Stringer, md at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise. (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.