MedTrace Logo

POLlinosis and Exhaled Breath Temperature

NCT01785394 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-02-07

No results posted yet for this study

Summary

The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.

Conditions

  • Pollinosis

Interventions

DRUG

5 grass allergen extract

30 patients will be subjected to sublingual immunotherapy with 5 grass allergen extract Staloral, starting with 1 spurt of 10 IR/ml increasing them daily stepwise to 10 spurts, switching then to 1 spurt of 300 IR/ml, increasing daily stepwise to 10 spurts, and then maintaining this dose from February till July. 30 patients will be on placebo.

Sponsors & Collaborators

  • Prof. Todor Popov

    lead OTHER

Principal Investigators

  • Todor Popov, MD, PhD · Professor of Allergology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Bulgaria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01785394 on ClinicalTrials.gov