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Study of Safety of Foradil in Patients With Persistent Asthma | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Study of Safety of Foradil in Patients With Persistent Asthma

A 26 Week, Randomized, Active-controlled Safety Study of Double-blind Formoterol Fumarate in Free Combination With an Inhaled Corticosteroid Versus an Inhaled Corticosteroid in Adolescent and Adult Patients With Persistent Asthma.

NCT01845025•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.

Detailed Description

This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints. The efficacy assessment is the secondary objective.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent, and assent if applicable, must be obtained before any assessment is performed.
•2. Male or female patients 12 years of age and older
•3. Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment.
•4. PEF≥50% of predicted normal value.
•5. Current and appropriate use of one of the treatments listed in the protocol for asthma.
•6. Recent asthma exacerbation between 30 days and 12 months prior to randomization that either:
•* required treatment with systemic corticosteroids (tablets, suspension, or injection) or
•* required hospitalization (defined as an inpatient stay or \>24-hour stay in an observation area in an emergency room or other equivalent facility)

Exclusion Criteria

•1. History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.
•2. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
•3. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
•4. History of smoking ≥ 10 pack years.
•5. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
•6. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
•7. Worsening/Unstable asthma within 7 days prior to randomization.
•8. Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization.
•9. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
•10. History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity.
+4 more criteria

Locations (27)

Novartis Investigative Site

Avondale, Arizona, United States

Novartis Investigative Site

North Hollywood, California, United States

Novartis Investigative Site

Bradenton, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Conyers, Georgia, United States

Novartis Investigative Site

Stone Mountain, Georgia, United States

Novartis Investigative Site

Louisville, Kentucky, United States

Novartis Investigative Site

Louisville, Kentucky, United States

Novartis Investigative Site

Covington, Louisiana, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

March 21, 2017

Enrollment

827

ACTUAL participants

Conditions

Persistent Asthma

Interventions

Formoterol 12 mcg

DRUG

Fluticasone propionate 100 mcg

DRUG

Fluticasone propionate 250 mcg

DRUG

Fluticasone propionate 500 mcg

DRUG

Placebo

DRUG

Asthma Research in Children and Adolescents

NCT04480242

Persistent AsthmaAsthma in Children+1 more

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COMPLETEDPHASE2

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Moderate to Severe Persistent Asthma

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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: March 21, 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 of Safety of Foradil in Patients With Persistent Asthma

Inclusion Criteria

Exclusion Criteria

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