Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04078009
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2019-08-28
Brief Title:
Standardising Nasal Allergen Challenge in Adult With Hay Fever
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Nasal Allergen Challenge Standardisation as a Surrogate for Hay Fever
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 investigate the clinical and immunological effects of allergen exposure and in using NAC as a surrogate outcome to assess the efficacy of treatments for allergic rhinitis The procedure is safe and well tolerated In order for NAC to be a valid tool it is essential that the allergen extracts used are standardised in terms of concentration and stability in solution We have previously used an extract of Timothy Grass Phleum pratense pollen Aquagen ALK-Abello Denmark Aquagen is supplied as a dry powder to be reconstituted prior to use by dissolving in an albumin-based diluent Unfortunately Aquagen production has been discontinued but the identical allergen is now available as Timothy Grass lyophilisate tablet Grazax ALK-Abello an approved and licensed product for treatment of severe seasonal allergic rhinitis Grazax consists of purified freeze-dried Timothy Grass pollen extract plus only three excipients gelatin from fish mannitol and sodium hydroxide Preliminary investigations have shown that Grazax tablets can be dissolved in saline to produce identical concentrations of allergen to Aquagen with the same stability profile in vitro We anticipate therefore that the clinical effect when used for nasal allergen challenges would be equivalent to the use of Aquagen for a given allergen concentration In this study we intend to confirm that nasal symptoms produced during the NAC with either Aquagen or Grazax will be equivalent We will recruit volunteers with grass pollen-induced hay fever to undergo NAC with each allergen source sequentially In an open randomised-order cross-over study The primary outcome will be patient-reported nasal symptoms according to a standardised scoring system in the 60 minutes after each nasal challenge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None