Clinical trial NCT01350128: PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An 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: 2011-05-09
Enrollment: 103
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 overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Detailed description: The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

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 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Secondary outcomes:
measure: Peak Change From Baseline in FEV1 on Day 1
timeFrame: Day 1
measure: Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
timeFrame: Day 1 (15 min, 30 min, 1 hour, 2 hours)
measure: Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
timeFrame: Day 1
measure: Peak Change From Baseline in IC on Day 1
timeFrame: Day 1
measure: Change From Baseline in Morning Pre-dose FEV1 on Day 7
timeFrame: Day 7
measure: Peak Change From Baseline in FEV1 on Day 7
timeFrame: Day 7
measure: Peak Change From Baseline in IC on Day 7
timeFrame: Day 7
measure: Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Panama City
country: United States
facility: Pearl Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Pearl Investigative Site
state: Florida
city: Cherry Hill
country: United States
facility: Pearl Investigative Site
state: New Jersey
city: Summit
country: United States
facility: Pearl Investigative Site
state: New Jersey
city: Charlotte
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Longview
country: United States
facility: Pearl Investigative Site
state: Texas
city: Richmond
country: United States
facility: Pearl Investigative Site
state: Virginia
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, M.D.
role: STUDY_DIRECTOR
References:
citation: Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6.