Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00135642
Study type Interventional
Source Imperial College London
Contact
Status Completed
Phase Phase 3
Start date February 1996
Completion date October 1998

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 NCT00537355 - An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00501527 - Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense 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 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 NCT00932256 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients Phase 1
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 NCT00135629 - Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever 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