Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00135629
Other study ID # DHRG-UpDosing
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2002
Est. completion date October 2008

Study information

Verified date May 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.


Description:

This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male and female 18-65 years of age - Written informed consent obtained before entering the trial - A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season - A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season - Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm) to Phleum pratense - Positive specific IgE against Phleum pratense (= IgE Class 2) - Physical examination with no clinically relevant findings - If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial - Willingness to comply with this protocol Exclusion Criteria: - FEV1 < 70% of predicted value - A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of - and potentially overlapping - the grass pollen season - A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed - A clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis - At randomisation, 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) - History of emergency visit or admission for asthma in the previous 12 months - Use of an investigational drug within 30 days prior to screening - Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years - History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis - History of angioedema - Any of the following underlying conditions known or suspected to be present: - Cystic fibrosis - Malignancy - Insulin-dependent diabetes - Malabsorption or malnutrition - Renal or hepatic insufficiency - Chronic infection - Drug dependency or alcoholism - Ischemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease) - Immunosuppressive treatment - History of hypersensitivity to the excipients of the trial medications - History of allergy, hypersensitivity or intolerance to trial medications or rescue medications - A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude - Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the grass pollen season

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).
Other:
Placebo Injection
Placebo Injection
Procedure:
Venepuncture: 100ml blood sample taken on 12 separate visits
Venepuncture: 100ml blood sample taken on 12 separate visits

Locations

Country Name City State
United Kingdom Royal Brompton Hospital, NHLI Imperial College London

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London ALK-Abelló A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Francis JN, James LK, Paraskevopoulos G, Wong C, Calderon MA, Durham SR, Till SJ. Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity. J Allergy Clin Immunol. 2008 May;121(5):1120-1125.e — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom and medication score recorded by subjects Overall assessment of symptoms was recorded on a numeric scale (-3 to +3) by each patient at the end of the study Assessment scores obtained after 12 months of treatment
Primary Adverse events (conjunctival symptoms) Conjunctival symptoms elicitation with P-pratense allergen (reduced response detection) 10 minutes post-conjunctival allergen provocation after 12 months of treatment
Secondary Intradermal allergen challenge All patients underwent re-peated venesection and intradermal allergen challenge for testing of early and late skin responses: allergen-induced cytokine production over 10 months (reduced response change to P pratense-specific antigens). Intradermal allergen challenge for testing of early and late skin responses at biweekly intervals during updosing and at monthly intervals during the maintenance phase. Biweekly during up-dosing and then monthly upto 6 months, and up to 12 months following initiation of treatment.
See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00851344 - Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo Phase 2
Completed NCT00501527 - Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense Phase 2
Completed NCT00537355 - An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00422149 - Twin SUBLIVAC® Grasses Clinical Efficacy Study Phase 3
Completed NCT00542607 - Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis Phase 4
Completed NCT00605852 - Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects Phase 1
Active, not recruiting NCT05960266 - Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study Early Phase 1
Completed NCT02256553 - Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006) Phase 4
Completed NCT00932256 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients Phase 1
Completed NCT01007721 - Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season Phase 2
Completed NCT00901914 - Study of rBet v1 Tablets Phase 2
Completed NCT00384475 - A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413) Phase 3
Completed NCT00839189 - Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults Phase 1
Completed NCT04687059 - An Exploratory Study of PQ Grass 27600 SU Phase 2/Phase 3
Completed NCT00889460 - Safety and Tolerability Study of rBet v1 SLIT Tablets Phase 1
Completed NCT00396149 - Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 Phase 1
Completed NCT00659594 - Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406) Phase 3
Completed NCT00127647 - An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327) Phase 3
Completed NCT01480271 - An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics. Phase 1