Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

NCT ID: NCT04622917

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2023-05-31

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.

Conditions

Rhinitis, Allergic, Seasonal; Hay Fever; Pollen Allergy; Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone

Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage

Group Type: ACTIVE_COMPARATOR

MethylPREDNISolone 40 Mg/mL Injectable Suspension

Intervention Type: DRUG

intramuscular injection

Sodium Chloride (NaCl)

NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage

Group Type: PLACEBO_COMPARATOR

NaCl 9 MG/ML Injectable Solution

Intervention Type: DRUG

Intramuscular injection

Interventions

MethylPREDNISolone 40 Mg/mL Injectable Suspension

intramuscular injection

Intervention Type: DRUG

NaCl 9 MG/ML Injectable Solution

Intramuscular injection

Intervention Type: DRUG

Other Intervention Names

Depo-Medrol; Sodium Chloride

Eligibility Criteria

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".

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Lars Olaf Cardell

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Olaf Cardell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Department of Lung-and Allergy Research

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

791-792

Identifier Type: -

Identifier Source: org_study_id