ACTIVE_NOT_RECRUITING

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).

Conditions

Chronic Obstructive Pulmonary Disease Metered Dose Inhalers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)

Quick Facts

Study Start:2023-10-24

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06067828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Research Site

Los Angeles, California, 90095

United States

Research Site

Tarzana, California, 91356

United States

Research Site

Torrance, California, 90502

United States

Research Site

Brooksville, Florida, 34613

United States

Research Site

Anderson, South Carolina, 29621

United States

Research Site

Greenville, South Carolina, 29615

United States

Research Site

Spartanburg, South Carolina, 29303

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2023-10-24

Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

Metered Dose Inhalers

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease