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A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

NCT04881461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2024-12-16

Study results available
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Summary

This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

Conditions

  • Allergy

Interventions

DRUG

5-grass mix SLIT-drops

Sublingual allergy immunotherapy drops, for daily administration

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Laurent Guilleminault, MD · CHU Hôpital Larrey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2023-09-26
Completion
2023-09-26

Countries

  • Czechia
  • Estonia
  • France
  • Latvia
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04881461 on ClinicalTrials.gov