Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
Information source: Dey
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: Peforomist-Placebo (Drug); Perforomist, nebulization, COPD (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Dey Official(s) and/or principal investigator(s): Dik Ng, Study Director, Affiliation: Mylan Pharma UK Ltd.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Incidence of respiratory death, first COPD-related emergency room visit, or first COPD exacerbation-related hospitalisation associated with long term use of Perforomist(R) Inhalation Solution
Secondary outcome: Incidence of all cause mortalityIncidence of COPD exacerbations Evaluate longitudinal changes in FEV1
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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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Locations and Contacts
Chandar Abboy, Greenville, South Carolina 29615, United States
Additional Information
Starting date: March 2012
Last updated: April 14, 2015
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