Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control

This study has been withdrawn prior to enrollment.
(Similar data obtained in another study [see NCT01085045], therefore study not implemented.)
Sponsor:
Information provided by:
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01043601
First received: January 5, 2010
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
COPD
Drug: Inhaled PT005
Drug: Inhaled Placebo
Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)
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 Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) 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 two doses of inhaled PT005 compared with placebo. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung Function Measures on Day 7 as measured by spirometry. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled PT005 7.2 µg Drug: Inhaled PT005
inhaled, twice daily for 1 week duration
Experimental: Inhaled PT005 9.6 µg Drug: Inhaled PT005
inhaled, twice daily for 1 week duration
Placebo Comparator: Inhaled Placebo Drug: Inhaled Placebo
inhaled, twice daily for 1 week duration
Active Comparator: Formoterol Fumarate 12 µg (Foradil Aerolizer) Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)
inhaled, twice daily for 1 week duration

  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
  • 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- 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
  • Competent at using the inhalation device

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 12 weeks of Screening
  • Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
  • Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
  • Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or 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 prohibited medications prior to screening and during the study as specified in the protocol
  • Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
  • Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
  • Unable to comply with study procedures
  • Prior participation in a Pearl PT005 study
  • Requires use of a spacer due to poor hand-to-breath coordination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043601

Locations
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Principal Investigator: Charles Fogarty, MD Spartanburg Medical Research
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01043601     History of Changes
Other Study ID Numbers: PT0051002
Study First Received: January 5, 2010
Last Updated: September 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
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 April 17, 2014