The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD

NCT03081156 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21752-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

chronic obstructive pulmonary disease (COPD); exercise intolerance; dynamic hyperinflation

Outcome Measures

Primary Outcomes (1)

• 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.

  8-12 weeks

Secondary Outcomes (1)

• VD/VT as Determined by Transcutaneous CO2 Measurement (tcpCO2) During Constant Work Rate Cycle Ergometer Exercise.

  8 to 12 weeks

Study Arms (2)

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.

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.

Drug: Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler

Interventions

Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler DRUG

Exercise Tolerance

Also known as: Bevespi AEROSPHERE

Glycopyrrolate/Formoterol Inhaler then Placebo Inhaler; Placebo Inhaler then Glycopyrrolate/Formeterol Inhaler

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• William Stringer, md: lead

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (1)

• 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.

  PMID: 33914661 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: William Stringer, MD
• Organization: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

stringer@ucla.edu

424-571-7626

Study Officials

• William W Stringer, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, Double Blind, Cross-Over Study

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 16, 2017
• Study Start: March 27, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 31, 2019
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)