Treatment Of Symptomatic Asthma In Children

NCT00197106 | Completed Phase 4 Results

• 1 other identifier: SAM101667
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Asthma

Keywords

salmeterol/fluticasone combination; Asthma; bronchial hyperresponsiveness; Children; symptom control

Outcome Measures

Primary Outcomes (1)

• Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period

  Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.

  Last 10 weeks of the treatment period (Weeks 16-26)

Secondary Outcomes (14)

• Percentage of Symptom-free Days During the Entire Treatment Period

  Baseline to Week 26

• Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26

  Baseline and Week 26

• Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26

  Baseline and Week 26

• Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26

  Baseline and Week 26

• Geometric Means of Nitric Oxide (NO) at Week 26

  Baseline and Week 26

Study Arms (2)

Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

ACTIVE COMPARATOR

Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

fluticasone propionate 2 x 100 mcg

OTHER

fluticasone propionate 2 x 100 mcg

Drug: fluticasone propionate 2 x 100 mcg

Interventions

Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg DRUG

comparator

Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

fluticasone propionate 2 x 100 mcg DRUG

comparator

Also known as: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

fluticasone propionate 2 x 100 mcg

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Almere Stad, 1315 RA, Netherlands

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Arnhem, 6815 AD, Netherlands

Location

GSK Investigational Site

Breda, 4819 EV, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Enschede, 7511JX, Netherlands

Location

GSK Investigational Site

Gouda, 2803 HG, Netherlands

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Helmond, 5707 HA, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

GSK Investigational Site

Maastricht, 6229 HX, Netherlands

Location

GSK Investigational Site

Nijmegen, 6532 SZ, Netherlands

Location

GSK Investigational Site

Sittard, 6131 BK, Netherlands

Location

GSK Investigational Site

The Hague, 2566 MJ, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

GSK Investigational Site

Veldhoven, 5504 DB, Netherlands

Location

GSK Investigational Site

Zwolle, 8025 AB, Netherlands

Location

Related Publications (1)

• Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ; COMBO Study Group. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1221-7. doi: 10.1164/rccm.201002-0193OC. Epub 2010 Jul 9.

  PMID: 20622031 DERIVED

MeSH Terms

Conditions

Asthma; Bronchial Hyperreactivity

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 14, 2017
• Results First Posted: December 14, 2009

Record last verified: 2012-04

Locations

NL (18)