6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old (VESTRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01462344
First received: October 27, 2011
Last updated: June 26, 2014
Last verified: June 2014
  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 children 4-11 years old 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: FLOVENT 100mcg
Drug: FLOVENT 250mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent 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 outcomes (asthma-related hospitalizations, endotracheal intubations, or deaths) over the 6-month study treatment period [ Time Frame: Within the 6 months post-randomization ] [ Designated as safety issue: Yes ]
  • Time to first asthma exacerbation [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and percent of subjects experiencing asthma-related deaths [ Time Frame: Within the 6 months post-randomization ] [ Designated as safety issue: Yes ]
  • The number and percent of subjects experiencing asthma-related endotracheal intubations [ Time Frame: Within the 6 months post-randomization ] [ Designated as safety issue: Yes ]
  • The number and percent of subjects experiencing asthma-related hospitalizations [ 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 treatment]) [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]
  • The number and percent of asthma control days [ Time Frame: Entire treatment period (up to 6 months) ] [ Designated as safety issue: No ]
    Asthma control days are defined as days without rescue albuterol/salbutamol use [other than pre-exercise treatment], nighttime awakenings due to asthma, asthma exacerbations, and missed work [caregiver] or school/daycare [subject) due to asthma, and when coughing from asthma score <=1 and wheezing score=0.


Estimated Enrollment: 6200
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
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
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
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Drug: ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Other Name: FSC 250/50
Active Comparator: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Drug: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Other Name: FP 100
Active Comparator: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Drug: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Other Name: FP 250

Detailed Description:

Progress of Enrollment, Updated Annually:

On November 17, 2011 the first study subject visit occurred. As of the cut-off date for the NDA Annual Report, April 24, 2013, 2,241 subjects have been randomized. The target enrolment is 6,200 subjects. The expected completion date for accrual and the study remains unchanged from August 2016 and February 2017 respectively.

Recruitment is in line with GSK expectations for the on-time completion of the study.

Next expected annual update: July 2014

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Consent to participate in the study
  2. Age 4-11 years old
  3. Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
  4. Asthma diagnosis for at least 6 months
  5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
  6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
  7. History of at least once occurrence of asthma exacerbation within the prior 12 months
  8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)

Exclusion Criteria:

  1. History of life-threatening asthma
  2. Unstable asthma
  3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
  4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
  5. Respiratory infection
  6. Subjects with only exercise-induced asthma
  7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
  8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
  9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
  10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
  11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
  12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
  13. Severe hypersensitivity to cow's milk proteins
  14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
  15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
  16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  17. 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: NCT01462344

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 471 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462344     History of Changes
Other Study ID Numbers: 115358
Study First Received: October 27, 2011
Last Updated: June 26, 2014
Health 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
Spain: Agencia Española del Medicamento y Productos Sanitarios
Belgium: Agence Fédérale des Medicaments et des Produits de la Santé
Finland: Finnish Medicines Agency
United States: Food and Drug Administration
Netherlands: Centrale Commissie Mensgebonden Onderzoek
Canada: Health Canada
Croatia: Ministry of Health and Social Welfare of the Republic of Croatia, Department of Drugs
Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Serbia: ALIMS - Medicines and Medical Devices Agency of Serbia
Thailand: Food and Drug Administration
Latvia: State Agency of Medicines
Chile: SFDA -State Food and Drug Administration
Italy: Coordinating site Local Competent Authority
Taiwan: Department of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Denmark: Lægemiddelstyrelsen
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
South Korea: Korea Food and Drug Administration (KFDA)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Korea: 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
Australia: Department of Health and Ageing Therapeutic Goods Administration
Malaysia: National Pharmaceutical Control Bureau
Sweden: Medical Products Agency
Russian Federation: Ministry of Health and social development of Russian Federation, Federal
China: Food and Drug Administration
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)
Turkey: Ministry of Health
India: Drugs Controller General of India (DCGI)
Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
pediatric
ADVAIR
FLOVENT
asthma

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 July 20, 2014