Viapaed Study In Children And Adolescents With Asthma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00315744 |
Recruitment Status :
Completed
First Posted : April 19, 2006
Last Update Posted : October 19, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Salmeterol/fluticasone Drug: Fluticasone propionate Drug: Salbutamol | Phase 4 |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
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. |
moderate asthma fluticasone children |
salmeterol steroid-sparing Asthma |
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 |