Standardising Nasal Allergen Challenge in Adult With Hay Fever

NCT04078009 | Completed

• 1 other identifier: 19IC5338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 mechanisms involved during allergic reactions to pollens in hay fever sufferers may provide improvements in diagnosis, drug treatment and assessment of their response to treatment. Controlled exposures to allergens such as grass pollen can provide important information on the mechanisms of allergic inflammation and may be used to assess the success of anti-allergy treatments. Nasal allergen challenge (NAC) is a useful tool in the investigation of allergic rhinitis, including grass pollen-induced seasonal allergic rhinitis (hay fever). NAC is performed by installation of a very small amount of grass pollen extract into the nose in order to reproduce mild and short-lived symptoms such as nasal itch, sneezing, runny nose and nasal congestion that you experience in a more severe form during natural exposure to grass pollen during the summer. Nasal allergen challenge has allowed us to explore the mechanism of hay fever and to provide a rapid and reliable method for investigating new potential treatments for hay fever. Nasal allergen Challenge is a very well-standardised and safe procedure that has been performed within the department of Allergy and Clinical Immunology at Imperial College and Royal Brompton Hospital for many years. Unfortunately the grass pollen extract ('Aquagen') that we have routinely used for nasal challenge has been discontinued and is therefore no longer available. The present study involves testing an alternative source of the grass pollen extract in the form of 'Grazax' which is a freeze-dried tablet that is highly standardised and should enable us to give an identical amount of grass pollen extract for the purpose of nasal challenge. We plan a 'head-to-head' comparison of the two extracts in nasal challenge in order to confirm that the two sources of allergen are equivalent thereby enabling us to use Grazax as the source of grass pollen extract for our nasal challenge studies in the future.

Conditions

Allergic Rhinitis

Keywords

Grass pollen allergy; Hayfever; Atopy; Allergic rhinitis; Nasal allergen challenge

Outcome Measures

Primary Outcomes (1)

• Total nasal symptoms scores after nasal allergen challenge

  To compare the total nasal symptom score at one hour after grass pollen nasal allergen challenge in Aquagen group versus Grazax group. Score ranges from 0-12 points. Higher score is more severe symptoms.

  60 minutes

Secondary Outcomes (2)

• Peak nasal inspiratory flow

  Baseline, 60 minutes

• Incidence of Adverse Events

  48 hours

Study Arms (2)

Aquagen (Starts with Aquagen and finish with Grazax)

EXPERIMENTAL

In order to explore a possible order effect with the challenges, in this single group cross-over trial, participants will be randomised (by computer-generated randomisation) to receive either Aquagen or Grazax as the first challenge, followed by the other allergen extract at the second challenge a minimum of 4 weeks later.

Diagnostic Test: Aquagen

Grazax (Starts with Grazax and finish with Aquagen)

EXPERIMENTAL

In order to explore a possible order effect with the challenges, in this single group cross-over trial, participants will be randomised (by computer-generated randomisation) to receive either Aquagen or Grazax as the first challenge, followed by the other allergen extract at the second challenge a minimum of 4 weeks later.

Diagnostic Test: Grazax

Interventions

Aquagen DIAGNOSTIC_TEST

To compare the clinical allergic response after direct installation of an aqueous solution of Aquagen Timothy Grass pollen extract via nasal allergen challenge with the clinical allergic response after direct installation of an aqueous solution of Grazax Timothy Grass lyophilisate tablets via nasal allergen challenge in grass pollen allergic individuals.

Also known as: Grazax Timothy Grass lyophilisate tablet

Aquagen (Starts with Aquagen and finish with Grazax)

Grazax DIAGNOSTIC_TEST

To compare the clinical allergic response after direct installation of an aqueous solution of Aquagen Timothy Grass pollen extract via nasal allergen challenge with the clinical allergic response after direct installation of an aqueous solution of Grazax Timothy Grass lyophilisate tablets via nasal allergen challenge in grass pollen allergic individuals.

Grazax (Starts with Grazax and finish with Aquagen)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Officials

• Prof Stephen Durham, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: An open labelled randomised to either start with Aquagen or Grazax NAC
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study assessing symptoms scores 4 weeks between the two assessments (Grazax NAC and Aquagen NAC) performed to avoid any carry-over effects of this cross-over design.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 4, 2019
• Study Start: September 26, 2019
• Primary Completion: May 29, 2020
• Study Completion: August 28, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)