Study to Evaluate the Safety of Long-Term Use of Perforom... | NCT01488019

NCT01488019

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Perforomist, nebulization, COPD	Experimental	Active	Drug: Perforomist, nebulization, COPD
Perforomist-Placebo	Placebo Comparator	Placebo	Drug: Perforomist-Placebo

Name	Type	Description	Arm Group Labels	Other Names
Perforomist-Placebo	Drug	Placebo vehicle, 2mL, twice daily for 52 weeks	Perforomist-Placebo

Outcomes Module

Primary Outcomes

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	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	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 Outcomes

Measure	Description	Time Frame
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality	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

Eligibility Module

Eligibility 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 (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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Name	Affiliation	Role
Dik Ng	Mylan Pharma UK Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Chandar Abboy		Greenville	South Carolina	29615	United States

ID	Title	Description
FG000	Perforomist Inhalation Solution	Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks
FG001	Matching Placebo	Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Perforomist Inhalation Solution	Active Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks
BG001	Matching Placebo	Placebo Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation

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.

Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.

Posted

Count of Participants

Participants

0 to 52 weeks

ID	Title	Description
OG000	Perforomist Inhalation Solution

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Perforomist Inhalation Solution	Active Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals