Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever

NCT00135629 | Completed Phase 3

• 1 other identifier: DHRG-UpDosing
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Hayfever; Sublingual Immunotherapy; Grass pollen immunotherapy; Late cutaneous response; Intradermal allergen challenge; Seasonal Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Intradermal allergen challenge

  Biweekly during up-dosing and then monthly upto 6 months, and up to 12 months following initiation of treatment.

Study Arms (2)

Immunotherpy Arm

EXPERIMENTAL

12 patients received active injections of an alum-adsorbed grass pollen vaccine

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

Placebo Arm

PLACEBO COMPARATOR

6 patients received placebo injections

Other: Placebo Injection; Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits

Interventions

Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ). BIOLOGICAL

Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).

Immunotherpy Arm

Placebo Injection OTHER

Placebo Injection

Placebo Arm

Venepuncture: 100ml blood sample taken on 12 separate visits PROCEDURE

Venepuncture: 100ml blood sample taken on 12 separate visits

Immunotherpy Arm; Placebo Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Imperial College London: lead
• ALK-Abelló A/S: collaborator

Study Sites (1)

Royal Brompton Hospital, NHLI Imperial College

London, SW3 6LY, United Kingdom

Location

Related 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.e2. doi: 10.1016/j.jaci.2008.01.072. Epub 2008 Apr 18.

  PMID: 18374405 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephen R Durham, Professor

  Royal Brompton Hospital, Imperial College, National Heart & Lung Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arm, randomized, double-blind trial

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 26, 2005
• Study Start: October 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

GB (1)