Viapaed Study In Children And Adolescents With Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315744
• Other study ID #: 102318
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2006
• Last updated: October 18, 2017
• Start date: November 4, 2004
• Est. completion date: April 12, 2007

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: April 12, 2007
• Est. primary completion date: April 12, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Fluticasone propionate
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
• Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Krozingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Belm	Niedersachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bobingen	Bayern
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bottrop	Nordrhein-Westfalen
Germany	GSK Investigational Site	Braunfels	Hessen
Germany	GSK Investigational Site	Cossebaude	Sachsen
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Euskirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Forchheim	Bayern
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt/Oder	Brandenburg
Germany	GSK Investigational Site	Freising	Bayern
Germany	GSK Investigational Site	Friedrichsfelde	Berlin
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen
Germany	GSK Investigational Site	Halle	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Harrislee	Schleswig-Holstein
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Kaufbeuren	Bayern
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kempen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Konstanz	Baden-Wuerttemberg
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lauf	Bayern
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lueneburg	Niedersachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuhaus am Rennweg	Thueringen
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Niedernhausen	Hessen
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Osnabrueck	Niedersachsen
Germany	GSK Investigational Site	Pegnitz	Bayern
Germany	GSK Investigational Site	Pfullendorf	Baden-Wuerttemberg
Germany	GSK Investigational Site	Remscheid	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rosenheim	Bayern
Germany	GSK Investigational Site	Schwaebisch-Hall	Baden-Wuerttemberg
Germany	GSK Investigational Site	Schwedt	Brandenburg
Germany	GSK Investigational Site	Schwetzingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Sinsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tauberbischofsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tuttlingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Welzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wesel	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wetzlar	Hessen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Willich	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wurzen	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Sträter 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in peak expiratory flow rate (PEFR) in % of reference value	PEFR is a person's maximum speed of expiration.	Up to Week 8
Secondary	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
Secondary	Percentage of subjects with a peak flow variability of 20%	Morning versus evening peak flow will be calculated and compared.	Up to Week 8
Secondary	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
Secondary	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

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