To Assess the Efficacy and Safety of PT010 Compared to PT... | NCT03081247

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal Study team decision not to proceed.

Expanded Access Info

Start Date

Apr 16, 2018Estimated

Primary Completion Date

Dec 7, 2018Estimated

Completion Date

Dec 7, 2018Estimated

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BGF 320/14.4/9.6 µg MDI BID	Experimental	Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)	Drug: BGF 320/14.4/9.6 µg MDI
BFF 320/9.6 µg MDI BID	Experimental	Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)	Drug: BFF 320/9.6 µg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGF 320/14.4/9.6 µg MDI	Drug	Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)	BGF 320/14.4/9.6 µg MDI BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)		Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in morning pre-dose trough FEV1		Week 12
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Colin Reisner, MD	Pearl Therapeutics, Inc.	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms