Status:
COMPLETED
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
Lead Sponsor:
Dey
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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). In...
Detailed Description
None provided.
Eligibility Criteria
Inclusion
- Able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions
- 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)
- 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.
- 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.
- 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
- 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.
- Clinically significant abnormal chest x-ray (CXR) (within the past 12 months) diagnostic of active/significant disease other than COPD.
- 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.
- Subjects who had radiation or chemotherapy within the previous 12 months.
- An abnormal laboratory test at screening deemed clinically significant and exclusionary by the Investigator.
- A history of hypersensitivity to study drugs or their components, including albuterol rescue.
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Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
1071 Patients enrolled
Trial Details
Trial ID
NCT01488019
Start Date
March 1 2012
End Date
January 1 2016
Last Update
June 12 2017
Active Locations (1)
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1
Chandar Abboy
Greenville, South Carolina, United States, 29615