Clinical trial NCT01349816: PT003 MDI Dose Confirmation Study
Official title: A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
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: 2011-05-09
Enrollment: 185
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 demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (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 (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 in the protocol

Primary outcomes:
measure: FEV1 AUC0-12
timeFrame: Day 7
Secondary outcomes:
measure: Peak Change From Baseline in FEV1
timeFrame: Day 1
measure: Time to Onset of Action
timeFrame: Day 1
measure: At Least 12% Improvement in FEV1
timeFrame: Day 1
measure: Peak Change in IC
timeFrame: Day 1
measure: Morning Pre-dose FEV1
timeFrame: Day 7
measure: FEV1 Through 6 Hours
timeFrame: Day 7
measure: Peak Change From Baseline in IC
timeFrame: Day 7
measure: Mean Evening Trough FEV1
timeFrame: Day 7
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Pearl Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Pearl Investigative Site
state: Colorado
city: Waterbury
country: United States
facility: Pearl Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Pearl Investigative Site
state: Florida
city: Stockbridge
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Minneapolis
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Brooklyn
country: United States
facility: Pearl Investigative Site
state: New York
city: Charlotte
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Spartanburg
country: United States
facility: Pearl Investigative Site
state: South Carolina
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, M.D.
role: STUDY_DIRECTOR
References:
citation: Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.