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

COPD Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01043601
• Other study ID #: PT0051002
• Status: Withdrawn
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: July 9, 2014
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2014
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inhaled PT005
inhaled, twice daily for 1 week duration
• Inhaled Placebo
inhaled, twice daily for 1 week duration
• Formoterol Fumarate 12 µg (Foradil Aerolizer)
inhaled, twice daily for 1 week duration

Locations

Country	Name	City	State
United States	Spartanburg Medical Research	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Lung Function Measures on Day 7 as measured by spirometry.		Day 7	No
Secondary	Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest		Day 7	Yes