Overview

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

Status:
Withdrawn
Trial end date:
2018-12-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pearl Therapeutics, Inc.
Treatments:
Budesonide
Formoterol Fumarate
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