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

NCT01488019 | Completed Phase 4 Results

• 1 other identifier: 201-085
• Study Type: interventional
• Target: 1,071
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• 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 (12)

• Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality

  0 to 52 weeks

• Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization

  0 to 52 weeks

• Number of Subjects With Protocol-Defined COPD Exacerbation

  0 to 52 weeks

• Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks

  0 to 52 weeks

• FEV1 Changes From Baseline at Months 3, 6, 9 and 12

  On treatment at months 3, 6, 9 and 12

Study Arms (2)

Perforomist, nebulization, COPD

EXPERIMENTAL

Active

Drug: Perforomist, nebulization, COPD

Perforomist-Placebo

PLACEBO COMPARATOR

Placebo

Drug: Perforomist-Placebo

Interventions

Perforomist-Placebo DRUG

Placebo vehicle, 2mL, twice daily for 52 weeks

Also known as: Perforomist

Perforomist-Placebo

Perforomist, nebulization, COPD DRUG

Perforomist, 20 mcg/2 mL, twice daily for 52 weeks

Also known as: Formoterol fumarate

Perforomist, nebulization, COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• A history of hypersensitivity to study drugs or their components, including albuterol rescue.

Sponsors & Collaborators

• Dey: lead

Study Sites (1)

Chandar Abboy

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dik Ng, PhD, Director Clinical Science
• Organization: Mylan UK

dik.ng@mylan.co.uk

+44 1304626895

Study Officials

• Dik Ng

  Mylan Pharma UK Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 8, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)