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A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents | Clinical Trials | Clareo Health

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A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma

NCT01444430•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Detailed Description

A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Eligibility

Age

12 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
•Male or Female, ≥12 years of age
•Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
•Patient must have history of at least 1 asthma exacerbation including one of the following:
•* requiring treatment with systemic corticosteroids
•* an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
•Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion Criteria

•Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
•Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
•Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
•An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
•Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
•Patient must not meet unstable asthma severity criteria as listed in the protocol
•Peak expiratory flow must not be below 50% o predicted normal
•Pregnancy, breast-feeding or planned pregnancy during the study

Locations (340)

Research Site

Birmingham, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Anchorage, Alaska, United States

Research Site

Gilbert, Arizona, United States

Research Site

Glendale, Arizona, United States

Research Site

Mesa, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Fort Smith, Arkansas, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Alhambra, California, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

December 15, 2016

Enrollment

12,460

ACTUAL participants

Conditions

Asthma

Interventions

Symbicort pMDI

DRUG

budesonide pMDI

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

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: December 15, 2016Data 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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A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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