Treatment Of Symptomatic Asthma In Children - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197106

Purpose

This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.

Condition	Intervention	Phase
Asthma	Drug: fluticasone propionate 2 x 100 mcg Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period [ Time Frame: Last 10 weeks of the treatment period (Weeks 16-26) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Symptom-free Days During the Entire Treatment Period [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Geometric Means of Nitric Oxide (NO) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Percent Change From Baseline in RINT Measurements at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Number of Asthma Exacerbations Per Treatment Group at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Daily FEV1 and PEF Via the Electronic Peakflow /FEV1 Meter (PIKO-1) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Frequency of Asthma Exacerbations (Discriminated on Severity) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Cumulative Number of Symptom-free Weeks Until the End of Treatment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks' [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week' [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment:	176
Study Start Date:	June 2005
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
arm 1: Active Comparator	Drug: fluticasone propionate 2 x 100 mcg comparator Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg comparator

Detailed Description:

A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Male or female subjects aged 6-12 years (inclusive)
A female is eligible to enter and participate in the study if she is:

of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)

Subjects with a documented history of asthma for at least 6 months
Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
Subjects who have a normal length SD score between -2SD and +2SD
Subjects who are able to use a Diskus inhaler
Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 < 5% between the two best measurements)
Subjects and their guardians, who have given written informed consent to participate in the study
Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
Subjects able to use Ventolin on an 'as required for symptoms' basis

Exclusion criteria:

Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
Subjects with a disorder that affects growth (e.g. Turner's syndrome)
Subjects who have received any investigational drugs within 4 weeks of visit 1
Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
Subjects who concurrently participate in another clinical study
Subjects who have previously been randomised in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197106

Locations

Netherlands
GSK Investigational Site
Breda, Netherlands, 4819 EV
GSK Investigational Site
Almere, Netherlands, 1315 RA
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Gouda, Netherlands, 2803 HG
GSK Investigational Site
Nijmegen, Netherlands, 6532 SZ
GSK Investigational Site
Helmond, Netherlands, 5707 HA
GSK Investigational Site
Zwolle, Netherlands, 8025 AB
GSK Investigational Site
Veldhoven, Netherlands, 5504 DB
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Hoorn, Netherlands, 1624 NP
GSK Investigational Site
Den Haag, Netherlands, 2566 MJ
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Sittard, Netherlands, 6131 BK
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Maastricht, Netherlands, 6229 HX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM101667, COMBO
Study First Received:	September 9, 2005
Results First Received:	September 11, 2009
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00197106 History of Changes
Health Authority:	Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by GlaxoSmithKline:

Children
Asthma
bronchial hyperresponsiveness
symptom control
salmeterol/fluticasone combination

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010