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 has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01475721
First received: November 17, 2011
Last updated: March 31, 2016
Last verified: December 2015
  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.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.


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:
  • Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) [ Time Frame: From Day 1 up to 26 weeks ] [ Designated as safety issue: No ]
    Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.

  • Number of Participants Experiencing at Least One Asthma Exacerbation [ Time Frame: From Day 1 up to 26 weeks ] [ Designated as safety issue: No ]
    An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.


Secondary Outcome Measures:
  • Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death [ Time Frame: From Day 1 up to 26 weeks ] [ Designated as safety issue: No ]
    Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.

  • Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation [ Time Frame: From Day 1 up to 26 weeks ] [ Designated as safety issue: No ]
    An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.

  • Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours [ Time Frame: From Day 1 up to 26 weeks ] [ Designated as safety issue: No ]
    Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.


Enrollment: 11751
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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 the NDA Annual Report, May 24, 2015, 11,751 subjects have been randomized. The target enrolment was 11,664 subjects. The expected completion date for accrual and the study is ahead of schedule. GSK conducted Last Subject Last Visit in June 4, 2015. Next expected annual update: July 2016
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475721

  Show 810 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01475721     History of Changes
Other Study ID Numbers: 115359 
Study First Received: November 17, 2011
Results First Received: December 3, 2015
Last Updated: March 31, 2016
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016