Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587079
• Other study ID #: PT003005
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2012
• Last updated: October 22, 2013
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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 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 in the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PT003
PT003 MDI administered as two puffs BID for 7 days
• PT001
PT001 MDI administered as two puffs BID for 7 days
• PT005
PT005 MDI administered as two puffs BID for 7 days
• Tiotropium inhalation powder
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Cincinnati	Ohio
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Fridley	Minnesota
United States	Pearl Investigative Site	Glendale	Arizona
United States	Pearl Investigative Site	Lafayette	Louisiana
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Morgantown	West Virginia
United States	Pearl Investigative Site	North Dartmouth	Massachusetts
United States	Pearl Investigative Site	Pensacola	Florida
United States	Pearl Investigative Site	Rancho Mirage	California
United States	Pearl Investigative Site	Rock Hill	South Carolina
United States	Pearl Investigative Site	San Antonio	Texas
United States	Pearl Investigative Site	Spartanburg	South Carolina
United States	Pearl Investigative Site	St. Louis	Missouri
United States	Pearl Investigative Site	Summit	New Jersey
United States	Pearl Investigative Site	Waterbury	Connecticut
United States	Pearl Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 AUC0-12	FEV1 AUC0-12 relative to baseline following chronic dosing (1 week).	7 days	No