Methylprednisolone injection in treatment of birch pollen induced allergic rhinitis

Phase 1

• Conditions: Seasonal birch pollen induced allergic rhinitis; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2018-004205-12-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-17
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Age between 18-40.
- Severe seasonal birch pollen induced allergic rhinitis symptoms for birch verified by skin prick test.
- Signed informed consent according to IHC/GCP, 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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”.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified