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

This study has been completed.
Information provided by (Responsible Party):
Dey Identifier:
First received: November 29, 2011
Last updated: August 4, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Drug: Peforomist-Placebo
Drug: Perforomist, nebulization, COPD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Dey:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • Incidence of all cause mortality [ Time Frame: Week 52 ]
  • Incidence of COPD exacerbations [ Time Frame: Week 52 ]
    COPD Exacerbations as defined per protocol

  • Evaluate longitudinal changes in FEV1 [ Time Frame: Week 52 ]

Enrollment: 1071
Study Start Date: March 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peforomist, nebulization, COPD
Drug: Perforomist, nebulization, COPD
Peforomist, 20 mcg/2 mL, twice daily for 52 weeks
Other Name: Formoterol fumarate
Placebo Comparator: placebo vehicle
Drug: Peforomist-Placebo
Placebo vehicle, 2mL, twice daily
Other Name: Perforomist


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01488019

United States, South Carolina
Chandar Abboy
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Study Director: Dik Ng Mylan Pharmaceuticals
  More Information

Responsible Party: Dey Identifier: NCT01488019     History of Changes
Other Study ID Numbers: 201-085
Study First Received: November 29, 2011
Last Updated: August 4, 2016

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017