Evaluating the effects of inhalers on exercise in COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of a metered dose inhaler containing Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) compared to a placebo and another inhaler with Budesonide and Formoterol Fumarate (BFF) on exercise parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD). It is a multicenter, three-treatment, three-period, cross-over design, where participants will be randomized to receive different treatments over a total duration of up to 14 weeks. The primary focus is on measuring isotime inspiratory capacity and exercise endurance time in patients experiencing breathlessness despite existing COPD therapies.

Why it matters

Who can join: the full rules

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 enrolled or entering a pulmonary rehabilitation program during the study.
* Participants who have cancer that has not been in complete remission for at least 5 years.
* Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator.
* Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
* Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler.
* Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
* A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1.
* Participants with contraindications to cardiopulmonary exercise testing (CPET).
* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period.
* Participants with lung lobectomy, lung volume reduction or lung transplantation.
* Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit.
* Known history of drug or alcohol abuse within 12 months.
* Any regular recreational use of marijuana in the 12 months.

Where it's running

• Research Site
  Torrance, California, United States Recruiting
• Research Site
  Brooksville, Florida, United States Recruiting
• Research Site
  Anderson, South Carolina, United States Recruiting
• Research Site
  Greenville, South Carolina, United States Recruiting
• Research Site
  Spartanburg, South Carolina, United States Recruiting
• Research Site
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.