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Allergo Journal

, Volume 27, Issue 6, pp 36–41 | Cite as

Positive and negative AIT trials: What makes the difference?

  • Roy Gerth van Wijk
Mini-Review
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Abstract

Background

Allergen immunotherapy has proven to be efficacious in allergic rhinitis and asthma. However, results from randomised clinical trials may vary substantially. Clinical trials may unexpectedly fail. The purpose of this review is to discuss the possible factors that may contribute to a successful or unsuccessful study.

Methods

Descriptive review exploring the possible causes of negative outcomes in allergen immunotherapy trials.

Results

A series of factors may lead to negative results. Among of these are underpowering of the study, low allergen content in tested extracts, insufficient allergen exposure during monitoring and recruitment of inappropriate patients. In addition, the choice of the primary endpoint may be critical.

Discussion

A clinical trial aims to evaluate the efficacy of an agent. However, studies with potential effective compounds may fail because of methodical issues. Sometimes, they are the cause of discrepancies between successful phase II and unsuccessful phase III trials. To understand more about failure of studies, investigators and editors should be encouraged to publish negative trials.

Schlüsselwörter

allergen immunotherapy randomised clinical trial endpoints negative study phase II trial phase III trial 

Abbrevations

AIT

Allergen immunotherapy

CI

Confidence interval

CONSORT

Consolidated standards of reporting trials

GAP

Grass SLIT tablet asthma prevention

HDM

House dust mite

ITT

Intention-to-treat

OR

Odds ratio

PAT

Preventive allergy treatment

RCT

Randomised clinical trial

RCT

Randomised controlled trial

SCIT

Subcutaneous immunotherapy

SLIT

Sublingual immunotherapy

TCS

Total combined symptom score

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  1. 1.Section of Allergology, Department of Internal MedicineErasmus Medical CentreRotterdamThe Netherlands

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