Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
This study is currently recruiting participants.
Verified November 2011 by Dey
Sponsor:
Dey
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01488019
First received: November 29, 2011
Last updated: May 17, 2013
Last verified: November 2011
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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:
- Change from baseline in FEV1 at 52 weeks [ Time Frame: Baseline and every 3 months for 52 weeks ] [ Designated as safety issue: Yes ]Spirometry
Secondary Outcome Measures:
- Change from baseline in SGRQ at 52 weeks [ Time Frame: Baseline and every 3 months for 52 weeks ] [ Designated as safety issue: No ]Quality of Life
| 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
|
Detailed Description:
The primary outcome measure is forced expiratory volume at one second (FEV1) and the secondary outcome measure is St. George's Respiratory Questionnaire (SGRQ)
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 including persistent presence of cough, sputum production and shortness of breath on effort
- 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 Criteria:
- 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 (Medical monitor should be contacted to confirm adequate diagnosis prior to randomization)
- 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 -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488019
Contacts
| Contact: Ketty Belizaire | 908-542-1999 | |
| Contact: Shannon McCue | 908-542-1999 |
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: | Imitiaz Chaudry, PhD | Dey Pharma |
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: | May 17, 2013 |
| 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 May 23, 2013