Clinical trial NCT01587079: Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-27
Enrollment: 159
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


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

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

Primary outcomes:
measure: FEV1 AUC 0-12 on Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Peak Change From Baseline in FEV1 on Treatment Day 1
timeFrame: Day 1
measure: Time to Onset of Action (>10% Improvement in FEV1) on Day 1
timeFrame: Day 1
measure: Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
timeFrame: Day 1
measure: Peak Change From Baseline in Inspiratory Capacity on Day 1
timeFrame: Day 1
measure: Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
timeFrame: Day 7
measure: Peak Change From Baseline in FEV1 on Day 7
timeFrame: Day 7
measure: Change From Baseline in Morning Pre-dose Trough IC on Day 7
timeFrame: Day 7
measure: Peak Change From Baseline IC on Day 7
timeFrame: Day 7
measure: Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
timeFrame: Day 7
measure: Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
timeFrame: Day 7
measure: Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
timeFrame: Day 7
measure: Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
timeFrame: Day 7
measure: Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Rancho Mirage
country: United States
facility: Pearl Investigative Site
state: California
city: Waterbury
country: United States
facility: Pearl Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Pearl Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Pearl Investigative Site
state: Florida
city: Lafayette
country: United States
facility: Pearl Investigative Site
state: Louisiana
city: North Dartmouth
country: United States
facility: Pearl Investigative Site
state: Massachusetts
city: Fridley
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: St. Louis
country: United States
facility: Pearl Investigative Site
state: Missouri
city: Summit
country: United States
facility: Pearl Investigative Site
state: New Jersey
city: Cincinnati
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Rock Hill
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Pearl Investigative Site
state: Texas
city: Morgantown
country: United States
facility: Pearl Investigative Site
state: West Virginia
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, MD
role: STUDY_DIRECTOR
References: