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) - Full Text View

Sponsor:	Pearl Therapeutics, Inc.
Information provided by (Responsible Party):	Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01085045

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: PT003 MDI Drug: PT005 MDI Drug: Placebo MDI Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®) Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Drug: PT001 MDI	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Formoterol Tiotropium bromide Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:

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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Day 7 time points for FEV1 are measured over 12 hours

Secondary Outcome Measures:

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) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Day 1 timepoints for FEV1 and IC are measured over 2 hours
Improvement in pre-dose FEV1, peak FEV1, peak improvement in IC, and trough FEV1 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Day 7 time points for FEV1 are measured over 12 hours
Mean daily peak expiratory flow rate [ Time Frame: Day 1 through Day 7 ] [ Designated as safety issue: No ]

Enrollment:	118
Study Start Date:	March 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Inhaled PT003 (Dose 1) PT003 MDI Dose 1	Drug: PT003 MDI Inhaled PT003 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT003 (Dose 2) PT003 MDI Dose 2	Drug: PT003 MDI Inhaled PT003 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT005 (Dose 1) PT005 MDI Dose 1	Drug: PT005 MDI Inhaled PT005 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT005 (Dose 2) PT005 MDI Dose 2	Drug: PT005 MDI Inhaled PT005 MDI administered as two puffs BID for 7 days
Placebo Comparator: Inhaled Placebo Placebo MDI	Drug: Placebo MDI Inhaled placebo administered as two puffs BID for 7 days
Active Comparator: Tiotropium bromide 18 μg (Spiriva Handihaler®) Tiotropium Bromide inhalation powder	Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®) Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol fumarate inhalation powder 12 μg	Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Experimental: Inhaled PT001 (Dose 1) PT001 MDI Dose 1	Drug: PT001 MDI Inhaled PT001 MDI administered as two puffs BID for 7 days

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085045

Locations

United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Australia, New South Wales
Austrials
Caringbah, New South Wales, Australia, 2229
Woolcock
Glebe, New South Wales, Australia, 2037
Austrials
Hornsby, New South Wales, Australia, 2077
Australia, Queensland
Austrials
Auchenflower, Queensland, Australia, 4066
Q-Pharm
Herston, Queensland, Australia, 4006
Australia, South Australia
Respiratory Research Foundation - Burnside War Memorial Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Lung Institute of WA
Nedlands, Western Australia, Australia, 6006
New Zealand
Greenlane Clinical Centre
Epsom, Auckland, New Zealand, 1051
NZ Respiratory & Sleep Institute
Greenlane East, Auckland, New Zealand, 1051
Waikato Hospital
Hamilton, Waikato, New Zealand, 3240
P3 Research
Crofton Downs, Wellington, New Zealand, 6143

Sponsors and Collaborators

Pearl Therapeutics, Inc.

Investigators

Study Director:

Colin Reisner, M.D.

Pearl Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01085045 History of Changes
Other Study ID Numbers:	PT0031002
Study First Received:	March 9, 2010
Last Updated:	May 10, 2012
Health Authority:	United States: Food and Drug Administration Australia: Human Research Ethics Committee New Zealand: Standing Committee on Therapeutic Trials (SCOTT) Committee New Zealand: Medsafe

Keywords provided by Pearl Therapeutics, Inc.:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 23, 2012