Status:
COMPLETED
Standardising Nasal Allergen Challenge in Adult With Hay Fever
Lead Sponsor:
Imperial College London
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Hay fever affects 1 in 4 of the UK population and has significant effects on the quality of life of sufferers. Allergy to grass pollen is the most common cause. A detailed understanding of the mechani...
Detailed Description
Nasal allergen challenge (NAC) is a useful tool in the investigation of allergic rhinitis, including grass pollen-induced seasonal allergic rhinitis (hay fever). We have experience in using NAC to inv...
Eligibility Criteria
Inclusion
- Adults age 18 to 65 years.
- A clinical history of moderate-severe grass pollen-induced allergic rhino conjunctivitis for at least 2 years with peak symptoms from mid-May to mid-July.
- Positive skin prick test response, defined as wheal diameter ≥ 5 mm, to timothy grass pollen.
- For women of childbearing age, a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
- The ability to give informed consent and comply with study procedures.
Exclusion
- History of previous grass pollen allergen immunotherapy at any time in the past.
- Pre-bronchodilator FEV1 \< 70% of predicted value at screening.
- A clinical history of symptomatic allergic rhinitis and/or asthma caused by an allergen other than grass pollen to which the participant is regularly exposed either seasonally (eg. tree pollen, weed pollen and moulds) or perennially (house dust mite, cat, dog dander).
- Perennial asthma requiring regular inhaled corticosteroids.
- History of emergency visit or hospital admission for asthma in the previous 12 months.
- History of chronic obstructive pulmonary disease
- History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
- History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, ear pain, pressure, or fullness.
- At screening visit, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
- History of life-threatening anaphylaxis or angioedema.
- Ongoing systemic immunosuppressive treatment.
- The use of any investigational drug within 30 days of the screening visit.
- The presence of any medical condition that the investigator deems incompatible with participation in the study.
- History of fish allergy with positive skin test and/or positive specific IgE test to vertebrate/finned fish (due to potential fish allergen exposure from fish-gelatin in Grazax).
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04078009
Start Date
September 26 2019
End Date
August 28 2020
Last Update
August 31 2021
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6LY