Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00880490
First received: April 9, 2009
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Inhaled PT005
Drug: Inhaled placebo
Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Phase 1
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, Five-period, Placebo and Active-controlled,Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of Inhaled PT005 in Patients With Moderate-to-Severe COPD, Compared to Open- Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control

Resource links provided by NLM:


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 across the three doses of inhaled PT005 compared with placebo. [ Time Frame: Serial FEV1 measured over 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of action (>10% improvement in FEV1 from baseline) [ Time Frame: Serial FEV1 measured over 12 hours ] [ Designated as safety issue: No ]
  • Peak FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ] [ Designated as safety issue: No ]
  • Trough FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ] [ Designated as safety issue: No ]
  • Peak inspiratory capacity (IC) [ Time Frame: Serial IC measured over 12 hours ] [ Designated as safety issue: No ]
  • Peak expiratory flow rate (PEFR) [ Time Frame: Serial PEFR measured over 12 hours ] [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Time Frame: Serial FVC measured over 12 hours ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled PT005 2.4 mcg
Drug: Inhaled PT005
single dose, inhaled
Experimental: 2
Inhaled PT005 4.8 mcg
Drug: Inhaled PT005
single dose, inhaled
Experimental: 3
Inhaled PT005 9.6 mcg
Drug: Inhaled PT005
single dose, inhaled
Placebo Comparator: 4
Inhaled Placebo
Drug: Inhaled placebo
single dose, inhaled
Active Comparator: 5
Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
Other Name: Foradil Aerolizer

  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
  • Fluency in written and spoken English
  • 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-salbutamol FEV1/FVC ratio of < or = 0.70
  • A measured post-salbutamol FEV1 > or = 40 and < or = 80% of predicted normal values
  • Demonstrated reversibility to a short acting beta agonist by either >12% and >150 ml improvement in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI or an absolute improvement of >200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI.
  • Competent at using the inhalation device

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 24 weeks of Screening
  • Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
  • Clinically significant medical conditions
  • Lower respiratory tract infection requiring antibiotics in past 6 weeks
  • Clinically significant abnormal ECG
  • Clinically significant uncontrolled hypertension
  • Positive Hepatitis B surface antigen or Hepatitis C antibody
  • Cancer that has not been in complete remission for at least 5 years
  • History of hypersensitivity to any beta2-agonists or any study drug component
  • History of severe milk protein allergy
  • Known or suspected history of alcohol or drug abuse
  • Medically unable to withhold short acting bronchodilators for 8-hours
  • Use of the medications below in specified time interval prior to Screening: 12-weeks: depot corticosteroids, intra-articular corticosteroids; 4 weeks: ICS >1000 μg/day of fluticasone propionate or equivalent, non-potassium sparing diuretics, P-glycoprotein inhibitors, CYP3A4 inhibitors; 1 week: tiotropium; 48 hours: oral beta agonists, long acting beta agonists, theophylline, zariflukast, montelukast, zileuton; 8 hours: ipratropium or ipratropium/salbutamol combination product, inhaled short acting beta agonists, xanthine containing foods
  • Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates,hydantoins, and carbamazepine and phenothiazines
  • Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
  • Diagnosis of sleep apnea that is uncontrolled
  • Participation in acute phase of pulmonary rehabilitation in prior 4 weeks or will enter acute phase of pulmonary rehabilitation program during study
  • Unable to comply with study procedures
  • Affiliated with Investigator site
  • Questionable validity of consent
  • A positive drug of abuse test at Screening lives prior to Screening, whichever is longer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880490

Locations
Australia, New South Wales
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037
Australia, Queensland
Australian Clinical Research Organisation
Auchenflower, Queensland, Australia, 4066
Mater Hospital
South Brisbane, Queensland, Australia, 4101
New Zealand
Primorus Clinical Trials
Christchurch, New Zealand, 8014
P3 Research
Wellington, New Zealand, 6035
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00880490     History of Changes
Other Study ID Numbers: PT0050801
Study First Received: April 9, 2009
Last Updated: October 11, 2010
Health Authority: Australia: Human Research Ethics Committee
New Zealand: Health and Disability Ethics Committees

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014