Clinical trial NCT03081247: To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline in morning pre-dose trough FEV1
timeFrame: Week 12
measure: Peak change from baseline in inspiratory capacity
timeFrame: Week 12
measure: Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Week 12
measure: Time to first clinically important deterioration (CID) in COPD
timeFrame: 12 weeks
measure: Change from baseline in average daily rescue Ventolin HFA use
timeFrame: 12 weeks
measure: Peak change from baseline in FEV1
timeFrame: Week 12
measure: Time to onset of action
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, MD
role: STUDY_DIRECTOR
References: