A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generat… (NCT05573464) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
United States559 participantsStarted 2022-09-27
Plain-language summary
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF;
✓. Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines;
✓. Participants who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening;
✓. Participants who have pre-bronchodilator FEV1 of \< 80% predicted normal at Visit 1;
✓. Participants who have post-bronchodilator FEV1/FVC ratio of \< 0.70 and post-bronchodilator FEV1 of ≥ 25% to \< 80% predicted normal at Visit 2;
✓. Participants who have CAT score ≥ 10 at Visit 1;
✓. Participants who are current/former smokers with a history of at least 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year);
✓. Participants who are willing and, in the opinion of the Investigator, able to adjust current COPD therapy, as required by the protocol;
Exclusion criteria
✕. Participants who have a documented history of physician-diagnosed asthma in the opinion of the Investigator based on thorough review of medical history and medical records, within 5 years of Visit 1;
✕. Participants who have COPD due to α1-Antitrypsin Deficiency;
What they're measuring
1
Number and Percentage of Participants With Serious Adverse Events
Timeframe: Over 12 weeks
2
Number and Percentage of Participants With Serious Adverse Events
Timeframe: Over 52 weeks
3
Number and Percentage of Participants With Non-serious Adverse Events >5%
Timeframe: Over 12 weeks
4
Number and Percentage of Participants With Non-serious Adverse Events >5%
Timeframe: Over 52 weeks
5
Number and Percentage of Participants With Adverse Events of Special Interest
Timeframe: Over 12 weeks
6
Number and Percentage of Participants With Adverse Events of Special Interest
. Participants with historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. Significant is defined as any uncontrolled disease or any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analyses;
✕. Sleep apnea that, in the opinion of the Investigator, cannot be controlled;
✕. Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease;
✕. Participant with moderate or severe COPD exacerbation or respiratory infection ending within 4 weeks prior to Visit 1 or during the Screening period;
✕. Participant who has had a SARS-CoV-2 infection in the 8 weeks prior to Visit 1 or during the Screening Period or that required hospitalization at any time prior to Visit 1 or during the Screening Period;
✕. Pulmonary resection or lung volume reduction surgery during the 26 weeks (6 months) prior to Visit 1 (ie, lobectomy, bronchoscopy lung volume reduction \[endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants\]);