A Phase 4 interventional study of MethylPREDNISolone 40 Mg/mL Injectable Suspension and NaCl 9 MG/ML Injectable Solution in Rhinitis, Allergic, Seasonal, Hay Fever and Pollen Allergy, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Karolinska Institutet · Phase 4, Interventional, and Treatment
This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 44 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage
Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension
NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage
Drug: NaCl 9 MG/ML Injectable Solution
intramuscular injection
Also known as: Depo-Medrol
Intramuscular injection
Also known as: Sodium Chloride
Mean Combined Medical- and Symptom score (CSMS)
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms) and use of rescue medication (3-point scale. 0=no medication, 1= oral and/or topical (eyes) non sedative H1 antihistamines (H1A), 2= intranasal corticosteroids with/without H1A) during the birch pollen season. CSMS 6-point scale (0=no symptoms and no use of medication, 5= severe symptoms and use of intranasal corticosteroids with/without H1A)
Time frame: 3 weeks
Mean symptom score
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
Time frame: 3 weeks
Effects on Quality of Life (QoL), SNOT
Changes in Sino Nasal Outcome Test 22 (SNOT-22) at trial start, after 1 and 3 weeks respectively. 22 questions, 6-point scale (0=no change in quality of life and 5=severe reduction in quality of life)
Time frame: 3 weeks
Effects on Quality of Life (QoL), RQLQ
Changes in Juniper Rhinitis Quality of Life Questionnaire (RQLQ) at trial start, after 1 and 3 weeks respectively. 28 questions, 7-point scale ((0=no change in quality of life and 6=severe reduction in quality of life)
Time frame: 3 weeks
Effects on Quality of Life (QoL), ACQ
Changes in Asthma Control Questionnaire (ACQ) at trial start, after 1 and 3 weeks respectively. 5 questions, 7-point scale ((0=no change in quality of life and 6=severe reduction in quality of life)
Time frame: 3 weeks
Plan to share: Yes — IPD of symptoms and use of medication during the trial will be part of the publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet