Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Karolinska Institutet44 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rhinitis, Allergic, Seasonal Hay Fever Pollen Allergy Allergic Rhinitis

Interventions

MethylPREDNISolone 40 Mg/mL Injectable SuspensionDRUG

intramuscular injection

NaCl 9 MG/ML Injectable SolutionDRUG

Intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. * Major metabolic disease. * Alcohol or drug abuse. * Mental incapability of coping with the study. * Known or suspected allergy to the study product. * Suspicion of or confirmed bacterial infection. * Known allergy to the study drugs, "rescue medication".

Locations (1)

Department of Lung-and Allergy Research

Lund, Skåne County, Sweden

Outcomes

Primary Outcomes

Mean Combined Medical- and Symptom score (CSMS)

Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms) and use of rescue medication (3-point scale. 0=no medication, 1= oral and/or topical (eyes) non sedative H1 antihistamines (H1A), 2= intranasal corticosteroids with/without H1A) during the birch pollen season. CSMS 6-point scale (0=no symptoms and no use of medication, 5= severe symptoms and use of intranasal corticosteroids with/without H1A)

Time frame: 3 weeks

Mean symptom score

Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)

Time frame: 3 weeks

Secondary Outcomes

Effects on Quality of Life (QoL), SNOT

Changes in Sino Nasal Outcome Test 22 (SNOT-22) at trial start, after 1 and 3 weeks respectively. 22 questions, 6-point scale (0=no change in quality of life and 5=severe reduction in quality of life)

Time frame: 3 weeks

Effects on Quality of Life (QoL), RQLQ

Changes in Juniper Rhinitis Quality of Life Questionnaire (RQLQ) at trial start, after 1 and 3 weeks respectively. 28 questions, 7-point scale ((0=no change in quality of life and 6=severe reduction in quality of life)

Time frame: 3 weeks

Effects on Quality of Life (QoL), ACQ

Changes in Asthma Control Questionnaire (ACQ) at trial start, after 1 and 3 weeks respectively. 5 questions, 7-point scale ((0=no change in quality of life and 6=severe reduction in quality of life)

Time frame: 3 weeks

Data from ClinicalTrials.gov

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