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The feasibility of airways hyperresponsiveness as an inclusion criterion for studies on childhood asthma

¹ Dept of Pediatrics, Isala Klinieken/Weezenlanden Hospital, 8000 GM, Zwolle, ² Dept of Pulmonology, University Hospital, Groningen, ³ Dept of Pediatrics, Medical Center Leeuwarden and ⁴ Dept of Pediatrics, Emma Children's Hospital, Amsterdam, the Netherlands

CORRESPONDENCE: P.L.P. Brand, Dept of Pediatrics, Isala Klinieken/Weezenlanden Hospital, PO Box 10500, 8000 GM, Zwolle, the Netherlands. Fax: 31 384242734

Keywords: airway hyperresponsiveness, childhood asthma, inclusion criterion

Received: July 24, 2000
Accepted January 3, 2001

This study was sponsored by GlaxoWellcome (the Netherlands).

The feasibility of moderately severe airway hyperresponsiveness (AH) was examined as an inclusion criterion for clinical trials in asthmatic children.

During the baseline period of a long-term clinical trial in asthmatic children, maintenance therapy with fluticasone (200 µg·day^–1) was stopped for a maximum of 8 weeks and methacholine challenges were performed at 2-week intervals or earlier if the patients' condition deteriorated. Patients were eligible to continue the study if the provocative dose of methacholine causing a 20% fall in forced expired volume in one second (FEV₁) (PD₂₀) was <80 µg.

Fifty-one per cent of the children did not develop a PD₂₀ <80 µg after withdrawal of fluticasone. Patients with or without a PD₂₀ <80 µg did not differ in duration of asthma, duration of treatment, or peak flow variation. Patients with a PD₂₀ <80 µg had higher levels of total and specific immunoglobulin-E, and lower levels of FEV₁ and mean maximal expiratory flow than patients with a PD₂₀ 80 µg. Forty-four per cent of the patients with a PD₂₀ 80 µg did not have any symptoms during the wash-out period and 39% of these patients remained free from symptoms during one year follow-up.

The results of this study suggest that recruiting asthmatic children for clinical trials may be difficult if airways hyperresponsiveness is used as the sole inclusion criterion.

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