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Viapaed Study In Children And Adolescents With Asthma

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ClinicalTrials.gov Identifier: NCT00315744
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.

Condition or disease Intervention/treatment Phase
Asthma Drug: Salmeterol/fluticasone Drug: Fluticasone propionate Drug: Salbutamol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma
Actual Study Start Date : November 4, 2004
Actual Primary Completion Date : April 12, 2007
Actual Study Completion Date : April 12, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects receiving salmeterol/fluticasone
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
 Drug: Salmeterol/fluticasone
Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.

Drug: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Active Comparator: Subjects receiving fluticasone
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
 Drug: Fluticasone propionate
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
Other Names:
  • Salmeterol
  • SERETIDE

Drug: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in mean morning peak expiratory flow (PEF) [ Time Frame: Baseline up to Week 8 ]
    The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects


Secondary Outcome Measures :
  1. Daily Asthma symptom score [ Time Frame: Up to Week 8 ]
    Asthma symptoms will be recorded separately for night and day using 2 symptom scores. Symptoms included will be coughing, wheezing, shortness of breath, feeling of tightness in the chest and nocturnal waking due to 1 or more of these symptoms. Score will range from 0-4 where 0 = no complaints and 4= person could not sleep due to asthma symptoms.

  2. Number of calendar days without asthma symptoms [ Time Frame: Up to Week 8 ]
    Number of calendar days without asthma symptoms will be defined as the sum of all days for which the patient documented an asthma symptom score of 0 (no complaints) for the day and the previous night.

  3. Number of necessary administrations of salbutamol [ Time Frame: Up to Week 8 ]
    The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.

  4. Number of weeks with good asthma control [ Time Frame: Up to Week 8 ]
    One week of well controlled asthma will be defined by fulfilling the following criteria: at least 2 of the following criteria (type A): symptoms with a symptom score >1 on at most 2 days, use of rescue medication maximally 4 x per week, morning PEF daily >=80% of the predicted normal value and all the following criteria (type B): no nocturnal waking due to bronchial asthma, no exacerbations, no out-patient or hospitalized emergency treatment due to asthma, no adverse events due to administration of the study medication which would have necessitated a change of treatment, no intolerance or refusal of study medication

  5. Change in forced vital capacity (FVC) in % of reference value [ Time Frame: Up to Week 8 ]
    FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath.

  6. Change in forced expiratory volume in 1 second (FEV1) in % of reference value [ Time Frame: Up to Week 8 ]
    FEV1 is the volume of air exhaled under forced conditions in 1 second.

  7. Change in peak expiratory flow rate (PEFR) in % of reference value [ Time Frame: Up to Week 8 ]
    PEFR is a person's maximum speed of expiration.

  8. Change in mean morning peak flow in % of reference value [ Time Frame: Up to Week 8 ]
    The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter

  9. Percentage of subjects with a peak flow variability of 20% [ Time Frame: Up to Week 8 ]
    Morning versus evening peak flow will be calculated and compared.

  10. Number of subject withdrawals due to asthma exacerbations [ Time Frame: Up to Week 8 ]
    Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms.

  11. Number of subjects with adverse events (AEs) [ Time Frame: Up to Week 8 ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 4 to 16 years with an established history of perennial asthma.
  • Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
  • 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
  • Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
  • Subjects/guardians who have given written informed consent to participate in the study.
  • Subjects /guardians who are able to understand and complete a diary record card (DRC).
  • Subjects who are able to use a Mini-Wright Peak Flow meter.
  • Sexually active female adolescents must use adequate contraception.
  • Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315744


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 102318
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00315744    
Other Study ID Numbers: 102318
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
moderate asthma
fluticasone
children
 salmeterol
steroid-sparing
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Albuterol
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
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
Tocolytic Agents
Reproductive Control Agents