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Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study (Pollen+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005627
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
King's College London
ALK-Abelló A/S
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for approximately 7 times more doctors' appointments than asthma. The standard treatment for hay fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in a survey taken in a UK general practice less than 40% of patients with hay fever reported good symptom control with this standard treatment. For those patients with hay fever whose symptoms are not well controlled by treatment with antihistamines and nasal sprays, subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a period of 3-5 years) is an effective alternative, and is approved in the UK on a named patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed, including grass pollen allergen tablets. These have been shown to be highly effective in the treatment of hay fever, with the additional benefit of being convenient for patients, given that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of troublesome grass pollen induced hay fever. The aim of this research is to investigate the effects of the AIT treatment on the immune system over time - which changes are taking place and when in the course of treatment. This will provide insight into the complexities of the development of allergen-specific immune tolerance - how harmful allergic responses against innocuous substances such as grass pollen can be overridden.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Grazax Drug: Grazax Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomised Placebo-controlled Study of Grass Pollen Allergen Immunotherapy Tablet (AIT) for Seasonal Rhinitis: Time Course of Nasal, Cutaneous and Immunological Outcomes
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Active Comparator: Grazax
The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily.
Drug: Grazax
The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.
Other Names:
  • Grazax 75,000 SQ-T oral lyophilisate
  • Allergen Immunotherapy Tablet
  • SQ Standardized Grass Allergy Immunotherapy

Placebo Comparator: Grazax Placebo
This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Drug: Grazax Placebo
This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Other Name: Grazax Placebo tablet




Primary Outcome Measures :
  1. Total Nasal Symptom Score After Nasal Allergen Challenge (NAC) [ Time Frame: 60 minutes post-challenge after 12 months of treatment ]
    The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.


Secondary Outcome Measures :
  1. Early Phase Intradermal Test [ Time Frame: after 12 months of treatment ]
    Mean Diameter in millimetre of EPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms.

  2. Late Phase Intradermal Test [ Time Frame: after 12 months of treatment ]
    Mean Diameter in millimetre of LPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms

  3. Change From Baseline in Delta Peak Nasal Inspiratory Flow in L/Min [ Time Frame: 60 minutes post-challenge after 12 months of treatment ]
    Nasal patency assessed at 60 minutes after nasal allergen challenge 12 months after treatment. The lower the peak nasal inspiratory flow the blockage nasal patency is.

  4. End of Season Global Rhinitis Symptoms [ Time Frame: after treatment at 12 months ]
    Hayfever symptoms during last pollen season after start of treatment. Score on a scale ranges from minimum 0 point to maximum of 100 points. Higher score is more severe symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Atopic Participants:

Inclusion Criteria:

  • age 18 to 65
  • grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May-July.
  • moderate to severe rhinoconjunctivitis symptoms with or without mild seasonal asthma interfering with usual daily activities/sleep.
  • rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
  • Positive skin prick test response (wheal diameter ≥ 3 mm) to timothy grass pollen.
  • Positive specific immunoglobulin E (IgE), defined as IgE immunoCAP ≥ 0.7 Immuno Solid Phase Allergenchip (ISAC) standardized units (ISU), against timothy grass pollen.
  • if applicable a negative urine pregnancy test 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.
  • A positive grass pollen nasal allergen challenge test as defined by a total nasal symptom score (TNSS) of at least 7/12 after 5 minutes with an allergen dose of 5,000 bioequivalent units (BU)/ml.

Exclusion Criteria:

  • Previous grass pollen allergen immunotherapy.
  • Prebronchodilator forced expiratory volume at one second (FEV1) < 70% of predicted value out of grass-pollen season.
  • A clinical history of symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly exposed.
  • Perennial asthma requiring regular inhaled corticosteroids.
  • Seasonal symptoms outside the grass-pollen season.
  • 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.
  • History of chronic sinusitis.
  • At screening visit evidence for upper respiratory tract infection.Participants may be re-evaluated for eligibility after symptoms resolve.
  • Current smokers or a history of ≥ 5 pack years.
  • 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.
  • Contraindications taking Grazax.

Non-Atopic:

Inclusion Criteria:

  • age 18 to 65.
  • Negative skin prick test response to timothy grass pollen and panel of aeroallergens.
  • Negative specific IgE, defined as IgE immunoCAP < 0.35 ISU, against timothy grass pollen.
  • If applicable 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 criteria:

  • Previous grass pollen allergen immunotherapy.
  • Prebronchodilator FEV1 < 70% of predicted value out of grass-pollen season.
  • symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly and perennially exposed (e.g. cat dander).
  • Perennial asthma requiring regular inhaled corticosteroids.
  • Seasonal symptoms outside or during the grass-pollen season.
  • 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.
  • History of chronic sinusitis.
  • At screening visit, current symptoms of upper respiratory tract infection. Participants may be re-evaluated for eligibility after symptoms resolve.
  • Current smokers or a history of ≥ 5 pack years.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005627


Locations
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United Kingdom
NHS Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
King's College London
ALK-Abelló A/S
Wellcome Trust
Investigators
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Principal Investigator: Stephen R Durham, Prof. Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Statistical Analysis Plan  [PDF] May 4, 2015
Study Protocol  [PDF] October 1, 2015
Informed Consent Form  [PDF] October 1, 2015

Publications of Results:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02005627    
Other Study ID Numbers: 13IC0847
2013-003732-72 ( EudraCT Number )
13/EM/0351 ( Other Identifier: United Kingdom (UK) Research Ethics Committee )
First Posted: December 9, 2013    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
grass pollen allergy
hayfever
atopy
allergic rhinitis
sublingual immunotherapy tablets
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs