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Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC) | Clinical Trials | Clareo Health

COMPLETEDNA

Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC)

NCT01983865•Fraunhofer-Institute of Toxicology and Experimental Medicine

View on ClinicalTrials.gov

Summary

This clinical validation study is aimed at establishing a birch pollen challenge in the Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether the challenge is dose dependent and reproducible.

Detailed Description

This is a mono-center, single-blind, placebo controlled study assessing nasal symptoms in patients with allergic rhinitis upon exposure to birch pollen in an environmental challenge chamber during a 4 hour challenge period with different concentrations of birch pollen versus placebo. Subjects with allergic rhinitis to birch pollen will be recruited from the Fraunhofer ITEM database or the surrounding communities. After the screening evaluation eligible subjects will undergo six challenge sessions in the environmental challenge chamber at intervals of at least one week. In order to determine dose response, the concentration of birch pollen in the atmosphere of the challenge chamber will be varied from 1000 birch pollen/m³ in the first period, 2000 birch pollen/m³ in the second period, 4000 birch pollen/m³ in the third period, 8000 birch pollen/m³in the fourth period to 0 birch pollen/m³ (only air) in the fifth period. In order to investigate reproducibility in addition to dose response, a challenge with one concentration previously used will be repeated in period six. The dose will be chosen by the Investigator according to the observed nasal symptoms. According to previous experience with grass pollen (Dactylis glomerata) the target symptom level for TNSS is around 6. Therefore, the dose to study reproducibility will be chosen where the average mean TNSS of the last two hours will be closest to six. If two doses are equally close, the higher dose will be chosen because this will allow to optimize the particle monitoring technique. In this regard, it is better to have a high particle concentration in order to separate specific particles from unspecific particles (originating from the subjects themselves).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects aged 18-65 years.
•Non smokers or ex-smokers with a history of less than 10 pack years, having been non-smokers for at least the last 12 months.
•History of allergic rhinitis to birch pollen. Subjects with mild intermittent asthma controlled with occasional use of as-needed short-acting beta-agonists can be included.
•Normal lung function (FEV1 ≥ 80 % predicted)
•Positive skin prick test for birch
•Able and willing to give written informed consent to take part in the study.
•Available to complete all study measurements
•Women will be considered for inclusion if they are:
•O Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
•O Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who were pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or met clinical criteria for menopause and had been amenorrhoeic for more than 1 year prior to the screening visit).
+1 more criteria

Exclusion Criteria

•History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
•Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
•Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to enrollment.
•Past or present disease, which as judged by the investigator, might have affected the outcome of this study. These diseases included, but were not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
•Any structural nasal abnormalities or nasal polyps on examination, history of frequent nose bleeding or recent nasal surgery.
•Conditions or factors, which made the subject unlikely to be able to stay in the Fraunhofer ECC for four hours.
•Specific Immunotherapy (SIT) within the last two years prior to screening
•Risk of non-compliance with study procedures
•Participation in another clinical trial 30 days prior to enrolment
•Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers)
+1 more criteria

Key Dates

Start Date

November 1, 2013

Primary Completion Date

January 1, 2014

Completion Date

February 1, 2014

Last Updated

February 19, 2014

Enrollment

ACTUAL participants

Conditions

Seasonal Allergic Rhinitis

Interventions

Exposure to birch pollen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC)

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

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Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.