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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Dey
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01488019
First received: November 29, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This study will be 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
COPD
Drug: Peforomist-Placebo
Drug: Perforomist, nebulization, COPD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

  • Evaluate longitudinal changes in FEV1 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1048
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peforomist, nebulization, COPD
Active
Drug: Perforomist, nebulization, COPD
Peforomist, 20 mcg/2 mL, twice daily for 52 weeks
Other Name: Formoterol fumarate
Placebo Comparator: placebo vehicle
Placebo
Drug: Peforomist-Placebo
Placebo vehicle, 2mL, twice daily
Other Name: Perforomist

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  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 ClinicalTrials.gov identifier: NCT01488019

Contacts
Contact: Rachel Bramley +44 1304 626254

Locations
United States, South Carolina
Chandar Abboy Recruiting
Greenville, South Carolina, United States, 29615
Contact: Chandar Abboy, MD         
Sponsors and Collaborators
Dey
Investigators
Study Director: Peter Philips, MD Mylan Pharma UK Ltd.
  More Information

No publications provided

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT01488019     History of Changes
Other Study ID Numbers: 201-085
Study First Received: November 29, 2011
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014