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PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PT005 MDI

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Formoterol Fumarate 24 μg (Foradil® Aerolizer®)

Placebo MDI

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking
A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
Able to change COPD treatment as required by protocol
Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and >150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)

Key Exclusion Criteria:

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery
Abnormal chest X-ray (or CT scan) not due to the presence of COPD
Hospitalized due to poorly controlled COPD within 3 months of Screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
Cancer that has not been in complete remission for at least 5 years
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined by the protocol

Sites / Locations

Pearl Investigative Site
Pearl Investigative Site
Pearl Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

PT005 MDI (Dose 1)

PT005 MDI (Dose 2)

PT005 MDI (Dose 3)

Placebo MDI

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Formoterol Fumarate 24 μg (Foradil® Aerolizer®)

Arm Description

PT005 MDI (Dose 1)

PT005 MDI (Dose 2)

PT005 MDI (Dose 3)

Placebo MDI

Formoterol fumarate inhalation powder 12 μg

Formoterol fumarate inhalation powder 24 μg

Outcomes

Primary Outcome Measures

Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo

The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.

Secondary Outcome Measures

Characterize the dose-response curve of PT005 MDI

The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies

Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events

Full Information

NCT ID

NCT01349868

First Posted

May 5, 2011

Last Updated

September 10, 2012

Sponsor

Pearl Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01349868

Brief Title

PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

Official Title

A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pearl Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PT005 MDI (Dose 1)

Arm Type

Experimental

Arm Description

PT005 MDI (Dose 1)

Arm Title

PT005 MDI (Dose 2)

Arm Type

Experimental

Arm Description

PT005 MDI (Dose 2)

Arm Title

PT005 MDI (Dose 3)

Arm Type

Experimental

Arm Description

PT005 MDI (Dose 3)

Arm Title

Placebo MDI

Arm Type

Placebo Comparator

Arm Description

Placebo MDI

Arm Title

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Arm Type

Active Comparator

Arm Description

Formoterol fumarate inhalation powder 12 μg

Arm Title

Formoterol Fumarate 24 μg (Foradil® Aerolizer®)

Arm Type

Active Comparator

Arm Description

Formoterol fumarate inhalation powder 24 μg

Intervention Type

Drug

Intervention Name(s)

PT005 MDI

Intervention Description

PT005 MDI taken as two inhalations

Intervention Type

Drug

Intervention Name(s)

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Other Intervention Name(s)

Foradil® Aerolizer®

Intervention Description

Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece

Intervention Type

Drug

Intervention Name(s)

Formoterol Fumarate 24 μg (Foradil® Aerolizer®)

Other Intervention Name(s)

Foradil® Aerolizer®

Intervention Description

Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece

Intervention Type

Other

Intervention Name(s)

Placebo MDI

Intervention Description

Matching placebo to PT005 MDI taken as two inhalations

Primary Outcome Measure Information:

Title

Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo

Description

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

Characterize the dose-response curve of PT005 MDI

Description

Time Frame

1 Day

Title

Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Signed written informed consent 40 - 80 years of age Clinical history of COPD with airflow limitation that is not fully reversible Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods Current/former smokers with at least a 10 pack-year history of cigarette smoking A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70 A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values Able to change COPD treatment as required by protocol Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and >150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA) Key Exclusion Criteria: Women who are pregnant or lactating Primary diagnosis of asthma Alpha-1 antitrypsin deficiency as the cause of COPD Active pulmonary diseases Prior lung volume reduction surgery Abnormal chest X-ray (or CT scan) not due to the presence of COPD Hospitalized due to poorly controlled COPD within 3 months of Screening Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) Cancer that has not been in complete remission for at least 5 years Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives Other inclusion/exclusion criteria as defined by the protocol

Facility Information:

Facility Name

Pearl Investigative Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

Pearl Investigative Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Pearl Investigative Site

City

Spartanburg

State/Province

South Carolina

Country

United States

12. IPD Sharing Statement

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PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

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