Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Karolinska Institute

Status and phase: Completed; Phase 4

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

Treatments: Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension; Drug: NaCl 9 MG/ML Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04622917

791-792

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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".

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

Sodium Chloride (NaCl)

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl 9 MG/ML Injectable Solution