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)

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085045
• Other study ID #: PT0031002
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2010
• Last updated: September 11, 2012
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2012
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics CommitteeNew Zealand: Standing Committee on Therapeutic Trials (SCOTT) CommitteeNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
• PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
• Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days
• Tiotropium bromide 18 µg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 µg (Spiriva Handihaler®) administered QD for 7 days
• Formoterol Fumarate 12 µg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 µg (Foradil® Aerolizer®) administered BID for 7 days
• PT001 MDI
Inhaled PT001 MDI administered as two puffs BID for 7 days

Locations

Country	Name	City	State
Australia	Respiratory Research Foundation - Burnside War Memorial Hospital	Adelaide	South Australia
Australia	Austrials	Auchenflower	Queensland
Australia	Austrials	Caringbah	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Woolcock	Glebe	New South Wales
Australia	Q-Pharm	Herston	Queensland
Australia	Austrials	Hornsby	New South Wales
Australia	Lung Institute of WA	Nedlands	Western Australia
New Zealand	P3 Research	Crofton Downs	Wellington
New Zealand	Greenlane Clinical Centre	Epsom	Auckland
New Zealand	NZ Respiratory & Sleep Institute	Greenlane East	Auckland
New Zealand	Waikato Hospital	Hamilton	Waikato
United States	American Health Research	Charlotte	North Carolina
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Spartanburg Medical Research	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline	Day 7 time points for FEV1 are measured over 12 hours	Day 7	No
Secondary	Peak FEV1, time to onset of action (greater than or equal to 10% improvement in mean FEV1), proportion of patients with greater than or equal to 12% improvement in FEV1 and peak improvement in inspiratory capacity (IC)	Day 1 timepoints for FEV1 and IC are measured over 2 hours	Day 1	No
Secondary	Improvement in pre-dose FEV1, peak FEV1, peak improvement in IC, and trough FEV1	Day 7 time points for FEV1 are measured over 12 hours	Day 7	No
Secondary	Mean daily peak expiratory flow rate		Day 1 through Day 7	No