Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)

NCT ID: NCT01488019

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1071 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-01-31

Brief Summary

This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.

Detailed Description

None provided.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Perforomist, nebulization, COPD

Active

Group Type: EXPERIMENTAL

Perforomist, nebulization, COPD

Intervention Type: DRUG

Perforomist, 20 mcg/2 mL, twice daily for 52 weeks

Perforomist-Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Perforomist-Placebo

Intervention Type: DRUG

Placebo vehicle, 2mL, twice daily for 52 weeks

Interventions

Perforomist-Placebo

Placebo vehicle, 2mL, twice daily for 52 weeks

Intervention Type: DRUG

Perforomist, nebulization, COPD

Perforomist, 20 mcg/2 mL, twice daily for 52 weeks

Intervention Type: DRUG

Other Intervention Names

Perforomist; Formoterol fumarate

Eligibility Criteria

Inclusion Criteria

1. Able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions

2. Male and female subjects at least 40 years of age with a medical diagnosis of COPD (i.e. persistent presence of dyspnea, cough or sputum production and a history of exposure to risk factors for the disease, such as tobacco smoke)

3. A current or prior history of at least 10 pack-years of cigarette smoking and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at randomization.

4. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study by using adequate contraception at study entry and throughout the trial. WOCBP will be advised to notify the Investigator of any change in their pregnancy status. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.

5. Able to complete all aspects of the study through the end of the study, including all visits and tests, and self-administration of study medications.

Exclusion Criteria

1. A medical diagnosis of asthma. Indication of a past history of asthma that is deemed inaccurate to a subject's current condition by the Investigator must be adequately addressed in the medical history.

2. Clinically significant abnormal chest x-ray (CXR) (within the past 12 months) diagnostic of active/significant disease other than COPD.

3. Evidence of any unstable or clinically significant hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than COPD that, in the opinion of the Investigator, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.

4. Subjects who had radiation or chemotherapy within the previous 12 months.

5. An abnormal laboratory test at screening deemed clinically significant and exclusionary by the Investigator.

6. A history of hypersensitivity to study drugs or their components, including albuterol rescue.

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• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dey

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dik Ng

Role: STUDY_DIRECTOR

Mylan Pharma UK Ltd.

Locations

Chandar Abboy

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

201-085

Identifier Type: -

Identifier Source: org_study_id