The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD (NCT03081156) | Clinical Trial Compass
CompletedPhase 4
The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD
United States52 participantsStarted 2017-03-27
Plain-language 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).
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise.
✕. 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).