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PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01349868
First received: May 5, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: PT005 MDI
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Other: Placebo 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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.


Secondary Outcome Measures:
  • Characterize the dose-response curve of PT005 MDI [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies

  • Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PT005 MDI (Dose 1)
PT005 MDI (Dose 1)
 Drug: PT005 MDI
PT005 MDI taken as two inhalations
Experimental: PT005 MDI (Dose 2)
PT005 MDI (Dose 2)
 Drug: PT005 MDI
PT005 MDI taken as two inhalations
Experimental: PT005 MDI (Dose 3)
PT005 MDI (Dose 3)
 Drug: PT005 MDI
PT005 MDI taken as two inhalations
Placebo Comparator: Placebo MDI
Placebo MDI
 Other: Placebo MDI
Matching placebo to PT005 MDI taken as two inhalations
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg
 Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Other Name: Foradil® Aerolizer®
Active Comparator: Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 24 μg
 Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Other Name: Foradil® Aerolizer®

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and >150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)

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 by the protocol

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349868

Locations
United States, Florida
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
United States, South Carolina
Pearl Investigative Site
Spartanburg, South Carolina, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01349868     History of Changes
Other Study ID Numbers: PT005003
Study First Received: May 5, 2011
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

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
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013