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Long-Term Effects of Sublingual Grass Therapy

NCT01335139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2017-06-02

No results posted yet for this study

Summary

The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

BIOLOGICAL

Sublingual immunotherapy (SLIT)

Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections.

BIOLOGICAL

Subcutaneous immunotherapy (SCIT)

Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control.

OTHER

Placebo

Participants randomized to double-placebo tablets and injections. This group was included as a negative control.

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • Imperial College London

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stephen Durham, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335139 on ClinicalTrials.gov