Last updated: 11/07/2018 18:47:16
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (Seretide®) and/or Fluticasone propionate (Flixotide®) based on PD20 methacholine and symptoms or based on symptoms only (Children Asthma Therapy Optimal)
Trial description: This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Salmeterol/Fluticasone propionate combination product
Drug: Fluticasone propionate
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nuijsink M, Hop W, Sterk PJ, De Jongste JC, Duiverman EJ, on Behalf of the CATO Study Group (the Hague, Rotterdam, Leiden, Groningen, The Netherlands). Risk factors for moderate exacerbations in childhood asthma. Eur Respir J 2004; 24: Suppl. 48, 163s
Nuijsink M, Hop W, Duiverman EJ, Sterk PJ, de Jongste JC, on behalf of the CATO study group, The Hague, Rotterdam, Groningen, Leiden, Netherlands. A Treatment Strategy Aimed To Improve BHR Improves Long-Term Course of FEV1 in Atopic Asthmatic Children. Proc. Am. Thorac. Soc. 2005;2(-):A131 Abs No C47 Poster:A16
Nuijsink M, Hop W, de Jongste JC, Duiverman EJ, Sterk PJ, on Behalf of the CATO Study Group Juliana Children's Hosp, The Hague; Erasmus Univ Med Cntr/Sophia Children's Hosp, Rotterdam; Univ Hosp, Groningen; Leiden Univ Med Cntr, Leiden, The Netherlands. Hospitalization Due to Severe Asthma Exacerbations in Childhood Asthma: Relationship with Bronchial Hyperressponsiveness. ATS 2004; Thematic Poster Session (Abstract Page: A151)
Nuijsink M, Hop W, de Jongste JC, Sterk PJ, , Duiverman EJ, on Behalf of the CATO Study Group Juliana Children's Hosp, The Hague; Erasmus Univ Med Cntr/Sophia Children's Hosp, Rotterdam; Leiden Univ Med Cntr, Leiden, The Netherlands; Univ Hosp, Groningen, the Netherlands. Perception of bronchoconstriction is associated with the severity of asthma in children. ERS 2005 abstract
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 1999 to December 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 16 Years
Accepts healthy volunteers
no
- Children with a documented history of asthma.
- Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
- History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
- Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
Inclusion and exclusion criteria
Inclusion criteria:
- Children with a documented history of asthma.
- Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
- Must be able to perform reproducible lung function tests.
- Must have a positive RAST or skin prick test.
- During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
Exclusion criteria:
- History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
- Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
- Received oral corticosteroids within 4 weeks prior to visit 1.
- Existence of any disorder that affects growth.
- Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2003-05-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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