Efficacy and Safety Study of Two Dose Levels of AZD2115 i... | NCT02109406

Studies
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD

NCT02109406

Sponsor

Pearl Therapeutics, Inc.

Status

Completed

Last Update Posted

Sep 2, 2020Actual

Enrollment

31Actual

Phase

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

AZD2115 Dose 1
AZD 2115, Dose 2
Placebo MDI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Apr 2, 2014

First Submission Date that Met QC Criteria

Apr 4, 2014

First Posted Date

Apr 9, 2014Estimated

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

Jul 15, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 16, 2014

Certification/Extension First Posted Date

Jul 18, 2014Estimated

Last Update Submitted Date

Aug 28, 2020

Last Update Posted Date

Sep 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD2115 Dose 1	Experimental	AZD 2115, Dose 1 administered as two inhalations BID	Drug: AZD2115 Dose 1
AZD 2115 Dose 2	Experimental	AZD 2115, Dose 2 administered as two inhalations BID	Drug: AZD 2115, Dose 2
Placebo MDI	Placebo Comparator	Placebo MDI administered as two inhalations BID	Drug: Placebo MDI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD2115 Dose 1	Drug	AZD 2115, Dose 1 administered as two inhalations BID	AZD2115 Dose 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline		14 Days

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in morning pre dose trough FEV1		14 Days
Peak change in FEV1		14 Days
Forced vital capacity (FVC) AUC0-12 relative to baseline

Other Outcomes

Measure	Description	Time Frame
Pharmacokinetics	Cmax, AUC0-12, AUC0-t, tmax, Apparent elimination half-life (t1/2), Apparent volume of distribution (Vd/F), Apparent total body clearance (CL/F)	Day 1 through Day 15
Safety	Safety will be assessed by adverse events (AEs), physical examination findings, dry mouth and tremor assessments, paradoxical bronchospasm, vital signs, electrocardiogram (ECG), and laboratory assessments.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
Current or former smokers with a history of ≥10 pack years of cigarette smoking.
Post-bronchodilator FEV1/FVC ratio of <70%.
Pre-bronchodilator FEV1 must be <80% predicted
Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.

Exclusion Criteria:

Pregnancy: Women who are pregnant or lactating.
Significant diseases other than COPD, ie., disease or condition 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.
Primary diagnosis of asthma.
Alpha-1 antitrypsin deficiency as the cause of COPD
Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.
Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.
Clinically significant abnormal ECG.

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

Facility	Status	City	State	ZIP	Country	Contacts
Pearl Therapeutics Study Site		Clearwater	Florida		United States
Pearl Therapeutics Study Site

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease