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Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) | Clinical Trials | Clareo Health

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

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)

NCT01488019•Dey

View on ClinicalTrials.gov

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.

Detailed Description

None provided.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.
•\-

Locations (1)

Chandar Abboy

Greenville, South Carolina, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

June 12, 2017

Enrollment

1,071

ACTUAL participants

Conditions

COPD

Interventions

Perforomist-Placebo

DRUG

Perforomist, nebulization, COPD

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Effect of Telenursing on Oral Health

NCT07462221

COPD

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RECRUITINGNA

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

NCT07351929

COPD Exacerbation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

Probiotics in Pulmonaty Rehabilitation for COPD

Effects of Eccentric Exercise Training in Patients With COPD

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