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.

Allergic Rhinitis

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.

Aquagen

Grazax

Royal Brompton Hospital

Standardising Nasal Allergen Challenge in Adult With Hay Fever

Nasal Allergen Challenge: Standardisation as a Surrogate for Hay Fever

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.

Area under the curve for peak nasal inspiratory flow (PNIF) (delta PNIF change from baseline) 0-60 minutes post NAC. Bland Altman plots will also be utilized for the analysis of the secondary endpoint of delta PNIF AUC.

To evaluate the safety and tolerability of the nasal allergen challenge administered with each allergen source (Aquagen or Grazax). Participant and investigator reported adverse events potentially related to study procedures, including nasal allergen challenge, will be recorded (typical symptoms of hay fever following nasal allergen challenge lasting less than 24 hours will not be considered adverse events). Frequency of adverse events will be tabulated by event, system organ class, severity, and procedure relatedness as per CTCAE v4.0.

Imperial College London

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.

An open labelled randomised to either start with Aquagen or Grazax NAC

Asthma

Latent Tuberculosis

Preceding incremental ascending dose study to be used to assess top safe dose.

TLR Agonist

Preceding incremental ascending dose study to be used to assess safe top dose.

Tuberculin nasal challenge

Timothy Grass Pollen

Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen: Monophosphoryl lipidA, Poly-inosine-cytosine, Poly-inosine-cytosine Stabilised With Poly-L-lysine and Carboxymethylcellulose, Resiquimod, Tuberculin and Timothy Grass Pollen

To develop a set of well tolerated, robust and reproducible (validated) nasal challenge systems with microbial constituents and allergen. To assess tolerability and clinical symptoms, measurements of peak nasal inspiratory flow, total nasal symptom scores as well as clincal examination of nasal mucosa will take place prior to and after administration of nasal challenge agents.

timothy-grass/fever

Standardising Nasal Allergen Challenge in Adult With Hay Fever

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen

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