A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered D… (NCT06067828) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).
United States171 participantsStarted 2023-10-24
Plain-language summary
This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
* Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
* Participant must have:
* a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) \< 0.7 at Visit 1
* a post-bronchodilator FEV1 ≥ 30% and \<80% predicted normal (moderate to severe COPD) at Visit 1.
* a score of ≥ 2 on the modified Medical Research Council at Visit 1.
* pre-bronchodilator FRC of \> 120% of predicted normal FRC values at Visit 1.
* a constant work rate test endurance time of 3 to 8 minutes at Visit 2.
* Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking
* Body mass index \< 40 kg/m2.
* Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception.
Exclusion Criteria:
* A current diagnosis of asthma, asthma- COPD-overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease and pulmonary hypertension.
* Historical or current evidence of a clinically significant disease
* Participants on oxygen therapy or that desaturate significantly (\<82%) during exercise.
* Participants who are en…
What they're measuring
1
Change from baseline in isotime Inspiratory capacity (IC)