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Ann Allergy Asthma Immunol. 2014 Jul;113(1):108-13. doi: 10.1016/j.anai.2014.03.019. Epub 2014 Apr 16.

Objective approach for fending off the sublingual immunotherapy placebo effect in subjects with pollenosis: double-blinded, placebo-controlled trial.

Author information

1
Clinic of Allergy & Asthma, Medical University Sofia, Sofia, Bulgaria.
2
Clinic of Allergy & Asthma, Medical University Sofia, Sofia, Bulgaria. Electronic address: ted.popov@gmail.com.

Abstract

BACKGROUND:

Symptom scoring for the assessment of allergen immunotherapy is associated with a substantial placebo effect.

OBJECTIVE:

To assess the ability of exhaled breath temperature (EBT), a putative marker of airway inflammation, to evaluate objectively the efficacy of grass pollen sublingual immunotherapy in a proof-of-concept study.

METHODS:

This was a double-blinded, placebo-controlled clinical trial in 56 subjects (mean ± SD 30 ± 12 years old, 33 men) sensitized to grass pollen. The objective measurements were EBT, spirometry, and periostin and high-sensitivity C-reactive protein in blood. Overall discomfort scored on a visual analog scale was used as a proxy for subjective symptoms. Evaluations were performed before, during, and after the grass pollen season.

RESULTS:

Fifty-one subjects (25 and 26 in the active treatment and placebo groups, respectively) were assessed before and during the pollen season. The mean pre- vs in-season increase in EBT was significantly smaller (by 59.1%) in the active treatment than in the placebo group (P = .030). Of the other objective markers, only the blood periostin level increased significantly during the pollen season (P = .047), but without intergroup differences. Subjectively, the mean pre- vs in-season increase in the visual analog scale score was 32.3% smaller in the active treatment than in the placebo group, although this difference did not reach statistical significance (P = .116).

CONCLUSION:

These results suggest that the efficacy of grass pollen sublingual immunotherapy can be assessed by EBT, a putative quantitative measurement of airway inflammation, which is superior in its power to discriminate between active and placebo treatment than a subjective assessment of symptoms assessed on a visual analog scale.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01785394.

PMID:
24745701
DOI:
10.1016/j.anai.2014.03.019
[Indexed for MEDLINE]
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