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Completed

NCT Number: NCT00315744

Viapaed Study In Children And Adolescents With Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Bad Krozingen, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmeterol/Fluticasone

Drug

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.

Fluticasone propionate

Drug

Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.

Other names: Salmeterol, SERETIDE

Salbutamol

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 19, 2006
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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