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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01462344
First received: October 27, 2011
Last updated: August 11, 2016
Last verified: August 2016
  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:
  • 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 6 months ] [ 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. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.

  • Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.


Secondary Outcome Measures:
  • Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.

  • Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.

  • Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.

  • Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.

  • Percentage of Rescue-free Days Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.

  • Percentage of Asthma Control Days Over the 6-month Study Treatment Period [ Time Frame: From Day 1 up to 6 months ] [ Designated as safety issue: No ]
    An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.


Enrollment: 6250
Study Start Date: November 2011
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.
  Eligibility

Ages Eligible for Study:   4 Years to 11 Years   (Child)
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

  Show 532 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: NCT01462344     History of Changes
Other Study ID Numbers: 115358 
Study First Received: October 27, 2011
Results First Received: May 2, 2016
Last Updated: August 11, 2016
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
Netherlands: Centrale Commissie Mensgebonden Onderzoek
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
United States: Food and Drug Administration
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
Canada: Health Canada
Austria: Austrian Medicines and Medical Devices Agency (AGES PharmMed)
Philippines: Bureau of Food and Drugs
South Korea: Korea Food and Drug Administration (KFDA)
Korea: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United Kingdom: Medicines and Healthcare Products Regulatory Agency
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
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on December 09, 2016