Clinical trial NCT01085045: Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) 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: 2010-03-11
Enrollment: 118
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 purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.


Eligibility criteria: 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

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 protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: FEV1 AUC 0-12 on Day 7
timeFrame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Secondary outcomes:
measure: Peak Change From BL in FEV1 on Day 1
timeFrame: Day 1
measure: Peak Change From BL in FEV1 on Day 7
timeFrame: Day 7
measure: Peak Change From BL in Inspiratory Capacity on Day 1
timeFrame: Day 1
measure: Peak Change From BL IC on Day 7
timeFrame: Day 7
measure: Time to Onset of Action >=10% Improvement in FEV1 on Day 1
timeFrame: Day 1
measure: Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
timeFrame: Day 1
measure: Change in Morning Pre-dose FEV1 on Day 7
timeFrame: Day 7
measure: 12 hr Post-dose Trough FEV1 on Day 7
timeFrame: Day 7
measure: Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
timeFrame: Day 7
measure: Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
timeFrame: Day 7
measure: Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
timeFrame: Day 7
measure: Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Caringbah
country: Australia
facility: Austrials
state: New South Wales
city: Glebe
country: Australia
facility: Woolcock
state: New South Wales
city: Hornsby
country: Australia
facility: Austrials
state: New South Wales
city: Auchenflower
country: Australia
facility: Austrials
state: Queensland
city: Herston
country: Australia
facility: Q-Pharm
state: Queensland
city: Adelaide
country: Australia
facility: Respiratory Research Foundation - Burnside War Memorial Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Lung Institute of WA
state: Western Australia
city: Epsom
country: New Zealand
facility: Greenlane Clinical Centre
state: Auckland
city: Greenlane East
country: New Zealand
facility: NZ Respiratory & Sleep Institute
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Crofton Downs
country: New Zealand
facility: P3 Research
state: Wellington
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, M.D.
role: STUDY_DIRECTOR
References:
citation: Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8.