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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: COPD
• Intervention / Treatment: Drug: Inhaled PT005; Drug: Inhaled Placebo; Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Inhaled Placebo	Drug: Inhaled Placebo; inhaled, twice daily for 1 week duration
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
Active Comparator: Formoterol Fumarate 12 µg (Foradil Aerolizer)	Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer); inhaled, twice daily for 1 week duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Lung Function Measures on Day 7 as measured by spirometry.	Day 7
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest	Day 7

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Principal Investigator: Charles Fogarty, MD, Spartanburg Medical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 5, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate
• Other Study ID Numbers: PT0051002