Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
Condition: COPD
Intervention: Perforomist-Placebo; Perforomist, nebulization, COPD
Intervention description: Placebo vehicle, 2mL, twice daily for 52 weeks; Perforomist, 20 mcg/2 mL, twice daily for 52 weeks
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1071.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

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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