Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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".