Asthma DMP for young children: no conclusions can be drawn regarding benefit and harm

It is unclear whether 2 to 4-year-olds with bronchial obstruction or asthma benefit from interventions specified in the disease management programme (DMP) for patients with asthma that, up until now, have only been available to older children. This is the conclusion of the final report by the Institute for Quality and Efficiency in Health Care (IQWiG), published on 6 May 2009. Both drug and non-drug interventions were examined. However, for most of the interventions established in the asthma DMP, there were no studies available that investigated the benefit and harm in young children.

IQWiG's final report is part of a commission package awarded by the Federal Joint Committee (G-BA). Using IQWiG expertise, the Committee is seeking an answer to the question whether the existing DMP should be extended to children of preschool age. DMPs are structured treatment programmes for the chronically ill. Until now, it has only been possible to register children from the age of 5 upwards on the asthma DMP. The Institute is investigating both treatment and diagnosis options.

Difficult to differentiate between asthma and bronchial obstruction in young children

Bronchial asthma often starts in early childhood, but is difficult to diagnose definitely in this age group. Many young children who show typical symptoms, such as coughing, wheezing, breathlessness or tightness in the chest, are free of symptoms by the time they reach school age. If children are to be registered on a DMP from the age of 2, then firstly the certainty of diagnosis is of paramount importance. Secondly, medical interventions must also be assessed with regard to which benefit and harm they could have for patients receiving asthma treatment but who do not suffer from this chronic illness.

Therapeutic interventions insufficiently investigated

IQWiG included in its analysis 14 interventions that are currently a component of the asthma DMP. These cover drugs for reliever and maintenance therapy as well as various non-drug interventions, such as sport, breathing therapy, education and training or psychological care.

In 12 out of these 14 interventions, no studies could be found that were of a sufficiently high quality to allow reliable conclusions to be drawn regarding the benefit or harm to children in the 2 to 4-year-old age group.

Only two studies on the inhaled corticosteroid, fluticasone propionate

There are clinical comparisons on fluticasone propionate, an inhaled corticosteroid, and the leukotriene receptor antagonist, montelukast. As both studies on fluticasone propionate show, the rate of acute exacerbations falls and the number of asthma-free days rises when this drug is administered. However, the advantages described must be balanced against an increased risk of harm in the form of growth retardation. Therefore, only a limited benefit of fluticasone propionate has been demonstrated.

There are 2 studies on the leukotriene receptor antagonist, montelukast, covering the age group in question. However, as they included patients who were not treated according to the German drug approval status, the results are not transferable to young children in Germany. For this reason, it is not possible to draw a conclusion regarding the benefit or harm of treatment with montelukast.

IQWiG found no evidence that the potential for benefit or harm from the 2 drugs investigated was different in children who later developed asthma than in children with bronchial obstruction who did not.

Report preparation procedure

IQWiG published the preliminary results in the form of the preliminary report in July 2008 and interested parties were invited to submit comments. When the comments stage ended, the preliminary report was revised and sent as a final report to the contracting agency, the Federal Joint Committee, in mid-March 2009. Documentation of the written comments and the minutes of the oral debate are published in a separate document simultaneously with the final report.

Contact: Tel +49(0)221-35685-0, info@iqwig.de