Grass Pollen Immunotherapy Using a Cluster Regime for Seasonal Rhinitis and Asthma
|Rhinitis, Allergic, Seasonal||Biological: Subcutaneous Alutard SQ grass pollen (Phleum pratense) Procedure: Venepuncture: 20 ml blood sample taken on 2 separate visits||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Double Blind Placebo Controlled Trial of Grass Pollen Immunotherapy Using a Cluster Regime|
- Symptom and medication score recorded by subjects
- Adverse events
- Rhinoconjunctivitis Quality of Life Questionnaire
- Seasonal bronchial hyperresponsiveness
- Intradermal allergen challenge
|Study Start Date:||February 1996|
|Estimated Study Completion Date:||October 1998|
This was a single centre, randomized, double-blind, placebo-controlled, parallel group study. The main aim 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. Forty-four patients with severe summer hay fever (of whom 36 reported seasonal chest symptoms and 28 had seasonal bronchial hyperresponsiveness) participated in a randomised double-blind, placebo-controlled, parallel group study. After symptom monitoring for one summer, participants matched placebo injections (n=22) in a rapid up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. Outcome measures included hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness.
Results: Significant reductions were observed in immunotherapy group compared with the placebo group in hay fever symptoms (49%, 15%: P = 0.1), medication scores (80%, 18%; P=.007), and seasonal chest symptoms (90%, 11%; P < .05). Impairment of overall quality of life (mean score of 7 domains) during the pollen season was less in the immunotherapy group than in the placebo group (median difference [95% CI], 0.8 [0.18-1.5]; P=.05=2]. During the pollen season, there was no change in airway methacholine PC20 (provocation concentration producing a 20% fall in FEV1) in the immunotherapy-treated group (P=5), compared with an almost 3 doubling-dose decrease in the placebo-treated group (P=.5), compared with an almost 3 doubling dose decrease in the placebo-treated group (P=.01, between-group difference). There were no significant local or systemic side effects during the study.
Conclusion: Grass pollen immunotherapy improves quality of life in seasonal allergic rhinitis and reduces seasonal asthma symptoms and bronchial hyperresponsiveness.
Note: Ongoing mechanistic studies and nasal biopsies studies until 2008
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135642
|Royal Brompton Hospital, NHLI Imperial College|
|London, United Kingdom, SW3 6LY|
|Principal Investigator:||Stephen R Durham, Professor||Royal Brompton Hospital, NHLI Imperial College London United Kingdom|