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This study has been withdrawn prior to enrollment.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: July 9, 2014
Last verified: July 2014
  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 ]

Enrollment: 0
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
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: 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: July 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014