- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488019
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
May 11, 2017 updated by: Dey
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
None provided.
Study Type
Interventional
Enrollment (Actual)
1071
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Greenville, South Carolina, United States, 29615
- Chandar Abboy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 (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)
- 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.
- 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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perforomist, nebulization, COPD
Active
|
Perforomist, 20 mcg/2 mL, twice daily for 52 weeks
Other Names:
|
Placebo Comparator: Perforomist-Placebo
Placebo
|
Placebo vehicle, 2mL, twice daily for 52 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation
Time Frame: 0 to 52 weeks
|
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study).
The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set.
An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
|
0 to 52 weeks
|
Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks
Time Frame: 0 to 52 weeks
|
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study).
The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set.
An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
|
0 to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality
Time Frame: 0 to 52 weeks
|
An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
|
0 to 52 weeks
|
Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization
Time Frame: 0 to 52 weeks
|
0 to 52 weeks
|
|
Number of Subjects With Protocol-Defined COPD Exacerbation
Time Frame: 0 to 52 weeks
|
COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.
The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event.
COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.
|
0 to 52 weeks
|
Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks
Time Frame: 0 to 52 weeks
|
COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event.
COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.
|
0 to 52 weeks
|
FEV1 Changes From Baseline at Months 3, 6, 9 and 12
Time Frame: On treatment at months 3, 6, 9 and 12
|
On treatment at months 3, 6, 9 and 12
|
|
FVC Changes From Baseline at Months 3, 6, 9 and 12
Time Frame: On treatment at months 3, 6, 9 and 12
|
On treatment at months 3, 6, 9 and 12
|
|
IC Changes From Baseline at Months 3, 6, 9 and 12
Time Frame: On treatment at months 3, 6, 9 and 12
|
On treatment at months 3, 6, 9 and 12
|
|
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12
Time Frame: On treatment at months 3, 6, 9 and 12
|
Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation.
Symptoms captures level of symptomatology.
Activity and Impact responses are either "yes" or "no".
Scoring is from 0 to 100; 0 = no life quality impairment.
A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status.
Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful.
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On treatment at months 3, 6, 9 and 12
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Transition Dyspnea Index
Time Frame: On treatment at months 3, 6, 9 and 12
|
The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI.
It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement).
The 3 components are summed to provide a total score ranging from -9 to +9.
The lower the score, the more deterioration in severity of dyspnea.
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On treatment at months 3, 6, 9 and 12
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Health Care Utilization and Economic Impact - Number of Emergency Department Visits
Time Frame: 0 to 52 weeks
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0 to 52 weeks
|
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Summary of Subjects Requiring Intubation or Non-Invasive Ventilation
Time Frame: 0 to 52 weeks
|
0 to 52 weeks
|
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Rescue Medication Usage
Time Frame: 0 to 52 weeks
|
Number of puffs of rescue medication (albuterol pMDI) used per day
|
0 to 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dik Ng, Mylan Pharma UK Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
December 7, 2011
First Posted (Estimate)
December 8, 2011
Study Record Updates
Last Update Posted (Actual)
June 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- 201-085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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