Clinical trial NCT01488019: Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 1071
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation
timeFrame: 0 to 52 weeks
measure: Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks
timeFrame: 0 to 52 weeks
Secondary outcomes:
measure: Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality
timeFrame: 0 to 52 weeks
measure: Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization
timeFrame: 0 to 52 weeks
measure: Number of Subjects With Protocol-Defined COPD Exacerbation
timeFrame: 0 to 52 weeks
measure: Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks
timeFrame: 0 to 52 weeks
measure: FEV1 Changes From Baseline at Months 3, 6, 9 and 12
timeFrame: On treatment at months 3, 6, 9 and 12
measure: FVC Changes From Baseline at Months 3, 6, 9 and 12
timeFrame: On treatment at months 3, 6, 9 and 12
measure: IC Changes From Baseline at Months 3, 6, 9 and 12
timeFrame: On treatment at months 3, 6, 9 and 12
measure: Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12
timeFrame: On treatment at months 3, 6, 9 and 12
measure: Transition Dyspnea Index
timeFrame: On treatment at months 3, 6, 9 and 12
measure: Health Care Utilization and Economic Impact - Number of Emergency Department Visits
timeFrame: 0 to 52 weeks
measure: Summary of Subjects Requiring Intubation or Non-Invasive Ventilation
timeFrame: 0 to 52 weeks
measure: Rescue Medication Usage
timeFrame: 0 to 52 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Chandar Abboy
state: South Carolina
Study officials:
affiliation: Mylan Pharma UK Ltd.
name: Dik Ng
role: STUDY_DIRECTOR
References: