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

COPD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488019
• Other study ID #: 201-085
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2011
• Last updated: August 4, 2016
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1071
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Peforomist-Placebo
Placebo vehicle, 2mL, twice daily
• Perforomist, nebulization, COPD
Peforomist, 20 mcg/2 mL, twice daily for 52 weeks

Locations

Country	Name	City	State
United States	Chandar Abboy	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Week 52	Yes
Secondary	Incidence of all cause mortality		Week 52	Yes
Secondary	Incidence of COPD exacerbations	COPD Exacerbations as defined per protocol	Week 52	Yes
Secondary	Evaluate longitudinal changes in FEV1		Week 52	No