NCT00135642

Brief Summary

The purpose of this study was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma. Hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness were recorded during the study period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 1996

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1996

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

First QC Date

August 25, 2005

Last Update Submit

September 13, 2023

Conditions

Rhinitis, Allergic, Seasonal

Keywords

HayfeverSubcutaneous ImmunotherapyGrass pollen immunotherapySeasonal Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Symptom and medication score recorded by subjects

  • Adverse events

Secondary Outcomes (3)

  • Rhinoconjunctivitis Quality of Life Questionnaire

  • Seasonal bronchial hyperresponsiveness

  • Intradermal allergen challenge

Interventions

Subcutaneous Alutard SQ grass pollen (Phleum pratense)BIOLOGICAL
Venepuncture: 20 ml blood sample taken on 2 separate visitsPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female 18-60 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 ≥ 5 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
  • Patients with seasonal asthma only if their baseline methacholine PC20 was greater than 2 mg/mL (normal range \> 16 mg/ mL)
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital, NHLI Imperial College

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Stephen R Durham, Professor

    Royal Brompton Hospital, NHLI Imperial College London United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

February 1, 1996

Study Completion

October 1, 1998

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

GB(1)