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

NCT01043601 | Withdrawn Phase 2

• 1 other identifier: PT0051002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

Inhaled PT005 7.2 µg

EXPERIMENTAL

Drug: Inhaled PT005

Inhaled PT005 9.6 µg

EXPERIMENTAL

Drug: Inhaled PT005

Inhaled Placebo

PLACEBO COMPARATOR

Drug: Inhaled Placebo

Formoterol Fumarate 12 µg (Foradil Aerolizer)

ACTIVE COMPARATOR

Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)

Interventions

Inhaled PT005 DRUG

inhaled, twice daily for 1 week duration

Inhaled PT005 7.2 µg; Inhaled PT005 9.6 µg

Inhaled Placebo DRUG

inhaled, twice daily for 1 week duration

Inhaled Placebo

Formoterol Fumarate 12 µg (Foradil Aerolizer) DRUG

inhaled, twice daily for 1 week duration

Formoterol Fumarate 12 µg (Foradil Aerolizer)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Charles Fogarty, MD

  Spartanburg Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

US (1)