To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Pearl Therapeutics

Status and phase

Withdrawn

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: BFF 320/9.6 µg

Drug: BGF 320/14.4/9.6 µg MDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT03081247

PT010017

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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