Treatment Of Symptomatic Asthma In Children

Asthma Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197106
• Other study ID #: SAM101667
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: May 31, 2012
• Start date: June 2005
• Est. completion date: October 2008

Study information

• Verified date: April 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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, ß2-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
comparator
• fluticasone propionate 2 x 100 mcg
comparator

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Almere
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Gouda
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Helmond
Netherlands	GSK Investigational Site	Hoorn
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Maastricht
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Sittard
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Veldhoven
Netherlands	GSK Investigational Site	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percentage of Symptom-free Days During the Entire Treatment Period	Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary	Baseline to Week 26	No
Secondary	Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.	Baseline and Week 26	No
Secondary	Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.	Baseline and Week 26	No
Secondary	Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.	Baseline and Week 26	No
Secondary	Geometric Means of Nitric Oxide (NO) at Week 26	Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.	Baseline and Week 26	No
Secondary	Percent Change From Baseline in RINT Measurements at Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.	Baseline and Week 26	No
Secondary	Number of Asthma Exacerbations Per Treatment Group at Week 26	An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.	Week 26	No
Secondary	Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26	PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.	Baseline and Week 26	No
Secondary	Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres	Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.	26 weeks	No
Secondary	Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)	Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.	26 weeks	No
Secondary	Frequency of Asthma Exacerbations (Discriminated on Severity)	The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.	26 weeks	No
Secondary	Cumulative Number of Symptom-free Weeks Until the End of Treatment	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.	26 weeks	No
Secondary	Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.	26 weeks	No
Secondary	Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.	26 weeks	No