Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Phase 4

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Hay Fever; Pollen Allergy; Allergic Rhinitis
• Interventions: Drug: NaCl 9 MG/ML Injectable Solution; Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

• Registration Number: NCT04622917
• Lead Sponsor: Karolinska Institutet

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Primary Completion: 2022-06-20
• Study Completion: 2023-05-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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".

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride (NaCl)	NaCl 9 MG/ML Injectable Solution	NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage
Methylprednisolone	MethylPREDNISolone 40 Mg/mL Injectable Suspension	Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage

Primary Outcome Measures

Name	Time	Method
Mean Combined Medical- and Symptom score (CSMS)	3 weeks	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)
Mean symptom score	3 weeks	Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)

Secondary Outcome Measures

Name	Time	Method
Effects on Quality of Life (QoL), SNOT	3 weeks	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)
Effects on Quality of Life (QoL), RQLQ	3 weeks	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)
Effects on Quality of Life (QoL), ACQ	3 weeks	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)

Trial Locations

Locations (1)

Department of Lung-and Allergy Research; 🇸🇪 Lund, Skane, Sweden