Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.
Detailed description
This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.
Interventions
DRUGBGF 320/14.4/9.6 µg MDI
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
DRUGBFF 320/9.6 µg
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
Sponsors
Pearl Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Signed Informed Consent * Subjects with an established clinical history of COPD * Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<80% predicted normal value * All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening * Current or former smokers with a history of at least 10 pack-years of cigarette smoking * Women of Non-childbearing potential * Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently Key
Exclusion criteria
* Significant diseases or conditions other than COPD, which in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study * Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception * Current diagnosis of asthma * Uncontrolled sleep apnea * Other Serious Respiratory Disorders * Hospitalized due to poorly controlled COPD within 6 weeks * Poorly Controlled COPD * Immune deficiency and/or severe neurological disorders affecting control of the upper airway * Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4) | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Peak change from baseline in inspiratory capacity | Week 12 |
| Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ) | Week 12 |
| Time to first clinically important deterioration (CID) in COPD | 12 weeks |
| Change from baseline in morning pre-dose trough FEV1 | Week 12 |
| Peak change from baseline in FEV1 | Week 12 |
| Time to onset of action | Day 1 |
| Change from baseline in average daily rescue Ventolin HFA use | 12 weeks |
Outcome results
None listed