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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving salmeterol/fluticasone | Experimental | Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo. |
|
| Subjects receiving fluticasone | Active Comparator | Eligible subjects will receive 60 individual fluticasone 100 microgram doses each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in mean morning peak expiratory flow (PEF) | 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 | Baseline up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Asthma symptom score | 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. | Up to Week 8 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19824054 | Background | Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Strater C, Steinkamp G; VIAPAED Study Group. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol. 2009 Nov;44(11):1132-42. doi: 10.1002/ppul.21120. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 102318 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Fluticasone propionate | Drug | Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route. |
|
|
| Salbutamol | Drug | Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication. |
|
| Number of calendar days without asthma symptoms | 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. | Up to Week 8 |
| Number of necessary administrations of salbutamol | The number of necessary administrations of salbutamol will be documented daily by subjects in the diary. | Up to Week 8 |
| Number of weeks with good asthma control | 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 | Up to Week 8 |
| Change in forced vital capacity (FVC) in % of reference value | FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath. | Up to Week 8 |
| Change in forced expiratory volume in 1 second (FEV1) in % of reference value | FEV1 is the volume of air exhaled under forced conditions in 1 second. | Up to Week 8 |
| Change in peak expiratory flow rate (PEFR) in % of reference value | PEFR is a person's maximum speed of expiration. | Up to Week 8 |
| Change in mean morning peak flow in % of reference value | The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter | Up to Week 8 |
| Percentage of subjects with a peak flow variability of 20% | Morning versus evening peak flow will be calculated and compared. | Up to Week 8 |
| Number of subject withdrawals due to asthma exacerbations | Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms. | Up to Week 8 |
| Number of subjects with adverse events (AEs) | 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. | Up to Week 8 |
| Bönnigheim |
| Baden-Wurttemberg |
| 74357 |
| Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Konstanz | Baden-Wurttemberg | 78464 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| GSK Investigational Site | Pfullendorf | Baden-Wurttemberg | 88630 | Germany |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Schwetzingen | Baden-Wurttemberg | 68723 | Germany |
| GSK Investigational Site | Sinsheim | Baden-Wurttemberg | 74889 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70499 | Germany |
| GSK Investigational Site | Tauberbischofsheim | Baden-Wurttemberg | 97941 | Germany |
| GSK Investigational Site | Tuttlingen | Baden-Wurttemberg | 78532 | Germany |
| GSK Investigational Site | Villingen-Schwenningen | Baden-Wurttemberg | 78056 | Germany |
| GSK Investigational Site | Welzheim | Baden-Wurttemberg | 73642 | Germany |
| GSK Investigational Site | Bobingen | Bavaria | 86399 | Germany |
| GSK Investigational Site | Forchheim | Bavaria | 91301 | Germany |
| GSK Investigational Site | Freising | Bavaria | 85354 | Germany |
| GSK Investigational Site | Kaufbeuren | Bavaria | 87600 | Germany |
| GSK Investigational Site | Lauf | Bavaria | 91207 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80337 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80939 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90449 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90473 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Pegnitz | Bavaria | 91257 | Germany |
| GSK Investigational Site | Rosenheim | Bavaria | 83026 | Germany |
| GSK Investigational Site | Frankfurt (Oder) | Brandenburg | 15236 | Germany |
| GSK Investigational Site | Schwedt | Brandenburg | 16303 | Germany |
| GSK Investigational Site | Braunfels | Hesse | 35619 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60316 | Germany |
| GSK Investigational Site | Kassel | Hesse | 34121 | Germany |
| GSK Investigational Site | Niedernhausen | Hesse | 65527 | Germany |
| GSK Investigational Site | Wetzlar | Hesse | 35576 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65205 | Germany |
| GSK Investigational Site | Belm | Lower Saxony | 49191 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Lüneburg | Lower Saxony | 21339 | Germany |
| GSK Investigational Site | Osnabrück | Lower Saxony | 49082 | Germany |
| GSK Investigational Site | Aachen | North Rhine-Westphalia | 52072 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33617 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44789 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44795 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Bottrop | North Rhine-Westphalia | 46242 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47137 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40599 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Euskirchen | North Rhine-Westphalia | 53879 | Germany |
| GSK Investigational Site | Gütersloh | North Rhine-Westphalia | 33332 | Germany |
| GSK Investigational Site | Halle | North Rhine-Westphalia | 33790 | Germany |
| GSK Investigational Site | Kempen | North Rhine-Westphalia | 47906 | Germany |
| GSK Investigational Site | Kleve-Materborn | North Rhine-Westphalia | 47533 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47389 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32427 | Germany |
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41462 | Germany |
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41469 | Germany |
| GSK Investigational Site | Oberhausen | North Rhine-Westphalia | 46145 | Germany |
| GSK Investigational Site | Remscheid | North Rhine-Westphalia | 42899 | Germany |
| GSK Investigational Site | Wesel | North Rhine-Westphalia | 46483 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55127 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54294 | Germany |
| GSK Investigational Site | Cossebaude | Saxony | 01462 | Germany |
| GSK Investigational Site | Döbeln | Saxony | 04720 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01067 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01169 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04279 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04317 | Germany |
| GSK Investigational Site | Wurzen | Saxony | 04808 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24944 | Germany |
| GSK Investigational Site | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| GSK Investigational Site | Harrislee | Schleswig-Holstein | 24955 | Germany |
| GSK Investigational Site | Friedrichsfelde | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Neuhaus am Rennweg | Thuringia | 98724 | Germany |
| GSK Investigational Site | Berlin | 10365 | Germany |
| GSK Investigational Site | Berlin | 10785 | Germany |
| GSK Investigational Site | Berlin | 10965 | Germany |
| GSK Investigational Site | Berlin | 10967 | Germany |
| GSK Investigational Site | Berlin | 10997 | Germany |
| GSK Investigational Site | Berlin | 12161 | Germany |
| GSK Investigational Site | Berlin | 12167 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Berlin | 13355 | Germany |
| GSK Investigational Site | Berlin | 14163 | Germany |
| GSK Investigational Site | Hamburg | 22045 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102318 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102318 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102318 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102318 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102318 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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