To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BGF 320/14.4/9.6 µg MDI
BFF 320/9.6 µg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BGF 320/14.4/9.6 µg MDI BID
BFF 320/9.6 µg MDI BID
Arm Description
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
Outcomes
Primary Outcome Measures
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
Secondary Outcome Measures
Change from baseline in morning pre-dose trough FEV1
Peak change from baseline in inspiratory capacity
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
Time to first clinically important deterioration (CID) in COPD
Change from baseline in average daily rescue Ventolin HFA use
Peak change from baseline in FEV1
Time to onset of action
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03081247
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Internal Study team decision not to proceed.
Study Start Date
April 16, 2018 (Anticipated)
Primary Completion Date
December 7, 2018 (Anticipated)
Study Completion Date
December 7, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGF 320/14.4/9.6 µg MDI BID
Arm Type
Experimental
Arm Description
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
Arm Title
BFF 320/9.6 µg MDI BID
Arm Type
Experimental
Arm Description
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
Intervention Type
Drug
Intervention Name(s)
BGF 320/14.4/9.6 µg MDI
Other Intervention Name(s)
PT010
Intervention Description
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
Intervention Type
Drug
Intervention Name(s)
BFF 320/9.6 µg
Other Intervention Name(s)
PT009
Intervention Description
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
Primary Outcome Measure Information:
Title
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in morning pre-dose trough FEV1
Time Frame
Week 12
Title
Peak change from baseline in inspiratory capacity
Time Frame
Week 12
Title
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
Time Frame
Week 12
Title
Time to first clinically important deterioration (CID) in COPD
Time Frame
12 weeks
Title
Change from baseline in average daily rescue Ventolin HFA use
Time Frame
12 weeks
Title
Peak change from baseline in FEV1
Time Frame
Week 12
Title
Time to onset of action
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, MD
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
Learn more about this trial
To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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