Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135642
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2005-08-25
Brief Title:
Grass Pollen Immunotherapy Using a Cluster Regime for Seasonal Rhinitis and Asthma
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Trial of Grass Pollen Immunotherapy Using a Cluster Regime
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 n22 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 01 medication scores 80 18 P007 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 08 018-15 P052 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 P5 compared with an almost 3 doubling-dose decrease in the placebo-treated group P5 compared with an almost 3 doubling dose decrease in the placebo-treated group P01 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
Results Significant reductions were observed in immunotherapy group compared with the placebo group in hay fever symptoms 49 15 P 01 medication scores 80 18 P007 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 08 018-15 P052 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 P5 compared with an almost 3 doubling-dose decrease in the placebo-treated group P5 compared with an almost 3 doubling dose decrease in the placebo-treated group P01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None