Methylprednisolone injection in treatment of birch pollen induced allergic rhinitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004205-12-SE

Enrollment

Registered

2018-12-17

Start date

2019-02-13

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal birch pollen induced allergic rhinitis

Interventions

Trade Name: Depo-Medrol® Injektionsvätska, suspension 40 mg/ml Product Name: Depo-medrol Pharmaceutical Form: Injection INN or Proposed INN: METHYLPREDNISOLONE ACETATE Other descriptive name: METHYL

Eligibility

Sex/Gender

All

Inclusion criteria

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

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”.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to placebo (intramuscular injected NaCl). ;Secondary Objective: To evaluate if Intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to traditional treatment with antihistamine, topical steroids and eye drops.;Primary end point(s): Difference in daily symptoms score of birch pollen induced allergic rhinitis between subjects treated with a single dose Depo-medrol or NaCl, during the five week monitoring period.;Timepoint(s) of evaluation of this end point: Difference in daily symptoms during the five week monitoring period.	—

Measure

Time frame

Main Objective: To evaluate if intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to placebo (intramuscular injected NaCl). ;Secondary Objective: To evaluate if Intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to traditional treatment with antihistamine, topical steroids and eye drops.;Primary end point(s): Difference in daily symptoms score of birch pollen induced allergic rhinitis between subjects treated with a single dose Depo-medrol or NaCl, during the five week monitoring period.;Timepoint(s) of evaluation of this end point: Difference in daily symptoms during the five week monitoring period.

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Secondary

Measure	Time frame
Secondary end point(s): Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols and bone turn over markers (CTX/C1NP). ;Timepoint(s) of evaluation of this end point: Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols pre-trial, 1 week, 3 weeks and 5 weeks after treatment is initiated. ACTH and cortisol levels pre- and post-trial. Bone turn over markers (CTX/C1NP) pre- and post-trial	—

Measure

Time frame

Secondary end point(s): Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols and bone turn over markers (CTX/C1NP). ;Timepoint(s) of evaluation of this end point: Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols pre-trial, 1 week, 3 weeks and 5 weeks after treatment is initiated. ACTH and cortisol levels pre- and post-trial. Bone turn over markers (CTX/C1NP) pre- and post-trial

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Countries

Sweden

Contacts

Public ContactCarl Skröder

Region Skåne

carlskroder@hotmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026