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POLlinosis and Exhaled Breath Temperature (POLET)

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ClinicalTrials.gov Identifier: NCT01785394
Recruitment Status : Unknown
Verified February 2013 by Prof. Todor Popov, Association Asthma, Bulgaria.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

Brief 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.

Condition or disease Intervention/treatment Phase
Pollinosis Drug: 5 grass allergen extract Phase 4

Detailed Description:

Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.

Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.

Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.

Statistical analysis: On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level <0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
Study Start Date : February 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Active Comparator: 5 grass allergen extract
30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July)
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.
Other Name: Staloral

Placebo Comparator: Placebo
30 patients will receive placebo
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.
Other Name: Staloral




Primary Outcome Measures :
  1. Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients. [ Time Frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6. ]
    The primary objective of the study is to evaluate the differences between the changes of exhaled breath temperature before and in the pollen season of subjects treated with 5 grass allergen extract applied sublingually and untreated control patients. Possible carry-over differences between the same two arms will be explored during the second year of the trial. Calculations will involve difference between assessment at month 6 and baseline for year 1 (2012) and in year 2 (2013) and comparisons between the two arms of the study will be made.


Secondary Outcome Measures :
  1. Effect of the treatment on symptoms and objective measurements in blood [ Time Frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6. ]
    Changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage, changes in blood cell counts, C-reactive protein, IL13 and periostin will be calculated (difference between assessment at month 6 and baseline) for year 1 (2012) and Year 2 (2013) and compared between the two arms of the study.



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Ages Eligible for Study:   5 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 60 randomized patients from either sex
  • age range 5-55 years
  • included patients should have a proven grass pollen sensitization

Exclusion Criteria:

  • age under or above the stated
  • lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785394


Locations
Bulgaria
Medical University Sofia, Department of Allergology
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Prof. Todor Popov
Investigators
Principal Investigator: Todor Popov, MD, PhD Professor of Allergology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Todor Popov, Associate Professor, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier: NCT01785394     History of Changes
Other Study ID Numbers: POLET-12-13
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Prof. Todor Popov, Association Asthma, Bulgaria:
pollinosis
sublingual immunotherapy
exhaled breath temperature

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases