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.

Condition(s) targeted: Asthma

Intervention: ADVAIR 100/50mcg (Drug); ADVAIR 250/50mcg (Drug); ADVAIR 500/50mcg (Drug); FLOVENT 100mcg (Drug); FLOVENT 250mcg (Drug); FLOVENT 500mcg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

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.

Official title: 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

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

Primary outcome:

Time to first event in the composite endpoint of serious asthma related events (i.e. asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death) over the 6-month treatment period

Time to first severe asthma exacerbation

Secondary outcome:

Number and percent of subjects experiencing asthma related hospitalization

Number and percent of subjects experiencing asthma related endotracheal intubation

Number and percent of subjects experiencing asthma related endotracheal death

The number of withdrawals from study treatment due to asthma exacerbation

The number and percent of rescue-free days (days without use of rescue albuterol/salbutamol (other than pre-exercise)

Detailed description: Progress of Enrollment, Updated Annually:

On November 18, 2011 the first study subject visit occurred.

As of the cut-off date for this report, April 24, 2012, 552 subjects have been randomized. The target enrolment is 11,664 subjects. The expected completion date for accrual and the study remains unchanged from August 2016 and February 2017 respectively.

While the study is in the early stages and only sites in the United States have been recruiting, progress is in line with GSK expectations for the on-time completion of the study.

Next expected annual update: July 2013

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- A Child in Care (CiC) is a child who has been placed under the control or protection

of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Orlando, Florida 32822, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

Starting date: November 2011
Last updated: November 21, 2012