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 | Completed

• 1 other identifier: 13-11 Grabi Pilot
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score (TNSS)

  TNSS measured every 20 minutes over 4 hours of birch pollen challenge in the ECC

  every 20 minutes

Study Arms (1)

Exposure to birch pollen

OTHER

Other: Exposure to birch pollen

Interventions

Exposure to birch pollen OTHER

Exposure to birch pollen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).
• O Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there was complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contracep-tives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).

You may not qualify if:

• 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)
• History of drug or alcohol abuse

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director Airway Research

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02