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. (AUSTRI)
This study is currently recruiting participants.
Verified November 2012 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01475721
First received: November 17, 2011
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: ADVAIR 100/50mcg Drug: ADVAIR 250/50mcg Drug: ADVAIR 500/50mcg Drug: FLOVENT 100mcg Drug: FLOVENT 250mcg Drug: FLOVENT 500mcg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 Frame: Within the 6 months post-randomization ] [ Designated as safety issue: Yes ]
- Time to first severe asthma exacerbation [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number and percent of subjects experiencing asthma related hospitalization [ Time Frame: Within the 6 months post randomization ] [ Designated as safety issue: Yes ]
- Number and percent of subjects experiencing asthma related endotracheal intubation [ Time Frame: Within the 6 months post randomization ] [ Designated as safety issue: Yes ]
- Number and percent of subjects experiencing asthma related endotracheal death [ Time Frame: Within the 6 months post randomization ] [ Designated as safety issue: Yes ]
- The number of withdrawals from study treatment due to asthma exacerbation [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]
- The number and percent of rescue-free days (days without use of rescue albuterol/salbutamol (other than pre-exercise) [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 11664 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ADVAIR 100/50mcg
experimental drug
|
Drug: ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Other Name: FSC 100/50
|
|
Experimental: ADVAIR 250/50mcg
experimental drug
|
Drug: ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Other Name: FSC 250/50
|
|
Experimental: ADVAIR 500/50mcg
experimental drug
|
Drug: ADVAIR 500/50mcg
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
Other Name: FSC 500/50
|
|
Active Comparator: FLOVENT 100mcg
active comparator
|
Drug: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Other Name: FP 100
|
|
Active Comparator: FLOVENT 250mcg
active comparator
|
Drug: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Other Name: FP 250
|
|
Active Comparator: FLOVENT 500mcg
active comparator
|
Drug: FLOVENT 500mcg
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
Other Name: FP 500
|
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
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475721
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, Florida | |
| GSK Investigational Site | Recruiting |
| Orlando, Florida, United States, 32822 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01475721 History of Changes |
| Other Study ID Numbers: | 115359 |
| Study First Received: | November 17, 2011 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Italy: Coordinating site Local Competent Authority Ukraine: Ministry of Health of Ukraine, State Expert Center (SEC) of the Ministry of Health of Ukraine Slovakia: State Institute for Drug Control Peru: Instituto Nacional de Salud Colombia: INVIMA European Union: European Medicines Agency Korea: Food and Drug Administration Belgium: Agence Fédérale des Médicaments et des Produits de la Santé Finland: Finnish Medicines Agency Netherlands: Centrale Commissie Mensgebonden Onderzoek Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Australia: Department of Health and Ageing Therapeutic Goods Adminstration Serbia: ALIMS - Medicines and Medical Devices Agency of Serbia China: Food and Drug Administration Thailand: Food and Drug Administration Japan: Ministry of Health Latvia: State Agency of Medicines United States: Food and Drug Administration Turkey: Ministry of Health of Turkey Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) Croatia: Ministry of Health and Social Welfare of the Republic of Croatia, Department of Drugs Lithuania: State Medicine Control Agency - Ministry of Health Norway: Norwegian Medicines Agency Denmark: Lægemiddelstyrelsen Spain:Agencia Espanola de Medicamentos y Productos Sanitarios Israel: State of Israel Ministry of Health, Health Technology and Infrastructure Administration, Medical Devices Department Austria: Austrian Medicines and Medical Devices Agency (AGES PharmMed) Philippines: Bureau of Food and Drugs Taiwan: Department of Health (DOH) South Korea: Korea Food and Drug Administration (KFDA) Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Chile: SFDA -State Food and Drug Administration Hong Kong: Department of Health Hungary: Országos Gyógyszerészeti Intézet South Africa: Medicines Control Council Germany: Bundesinstitut für Arzneimittel und Medizinprodukte France: Agence Française de Sécurité Sanitaire des Produits de Santé United Kingdom: Medicines and Healthcare Products Regulatory Agency Malaysia: National Pharmaceutical Control Bureau Czech: State Institute for Drug Control Russian Federation: Ministry of Health and social development of Russian Federation, Federal Canada: Health Canada New Zealand: Medsafe (New Zealand Medicines and Medical Devices Safety Authority) Brazil: Agência Nacional de Vigilância Sanitária (ANVISA) Bulgaria: Bulgarian Drug Agency (BDA) Romania: National Medicine and Medical Devices Agency (NMMDA) India: Drugs Controller General of India (DCGI) |
Keywords provided by GlaxoSmithKline:
|
ADVAIR Asthma safety FLOVENT |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 21, 2013