Loading clinical trials...

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect

NCT04622917•Karolinska Institutet

Summary

This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.

Detailed Description

The study was an interventional single center double-blinded human randomized trial with two groups treated parallel.The first group received an intramuscular injection of Methylprednisolone 40 mg/ml 2ml x 1 as a single dose. The second group received an intramuscular injection of NaCl 0,9 mg/ml 2ml x 1 as a single dose. Symptom score and the use of medication was registered daily during the pollen peak of the season, using an electronic diary. The study was conducted during the spring of 2019.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Severe birch pollen induced allergic rhinitis.
•Signed informed consent according to International Council of Harmonisation/Good Clinical Practice, and national/local regulations.
•Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.

Exclusion Criteria

•Pregnancy or nursing.
•Autoimmune or collagen disease.
•Cardiovascular disease.
•Hepatic disease.
•Renal disease.
•Cancer.
•Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive- and restrictive lung disease).
•Medication with a possible side-effect of interfering with the immune response.
•Previous immuno- or chemotherapy.
•Chronic disease.
+6 more criteria

Locations (1)

Department of Lung-and Allergy Research

Lund, Skåne County, Sweden

Key Dates

Start Date

April 10, 2019

Primary Completion Date

June 20, 2022

Completion Date

May 31, 2023

Last Updated

March 15, 2024

Enrollment

ACTUAL participants

Conditions

Rhinitis, Allergic, SeasonalHay FeverPollen AllergyAllergic Rhinitis

Interventions

MethylPREDNISolone 40 Mg/mL Injectable Suspension

DRUG

NaCl 9 MG/ML Injectable Solution

DRUG

Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients

NCT03727399

Pollen Allergy

View study

COMPLETEDPHASE2

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

NCT04502966

Allergic RhinoconjunctivitisGrass Pollen Allergy

View study

COMPLETEDNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Inclusion Criteria

Exclusion Criteria

Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever