Loading clinical trials...

COMPLETEDPHASE4

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

NCT01475721•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Detailed Description

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provided consent to participate in the study
•Male or female, 12 years of age and older
•Clinical diagnosis of asthma for at least 1 year prior to the randomization
•Clinic PEF of greater than or equal to 50% of predicted normal value
•Subject must be appropriately using one of the treatments for asthma listed in the protocol
•Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
•Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
•requiring treatment with systemic corticosteroids
•an asthma-related hospitalization

Exclusion Criteria

•History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
•Concurrent respiratory disease other than asthma
•Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
•Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
•Presence of a bacterial or viral respiratory infection that is not resolved at randomization
•An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
•More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
•Subject must not meet unstable asthma severity criteria as listed in the protocol
•Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
•Pregnancy, breast-feeding or planned pregnancy during the study
+1 more criteria

Locations (808)

GSK Investigational Site

Athens, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Florence, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Montgomery, Alabama, United States

GSK Investigational Site

Pell City, Alabama, United States

GSK Investigational Site

Scottsboro, Alabama, United States

GSK Investigational Site

Toney, Alabama, United States

Key Dates

Start Date

November 18, 2011

Primary Completion Date

June 23, 2015

Completion Date

June 23, 2015

Last Updated

August 6, 2018

Enrollment

11,751

ACTUAL participants

Conditions

Asthma

Interventions

ADVAIR 100/50mcg

DRUG

ADVAIR 250/50mcg

DRUG

ADVAIR 500/50mcg

DRUG

FLOVENT 100mcg

DRUG

FLOVENT 250mcg

DRUG

FLOVENT 500mcg

DRUG

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

RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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: August 6, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

Inclusion Criteria

Exclusion Criteria

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

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma