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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04622917
Other study ID # 791-792
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 10, 2019
Est. completion date May 31, 2023

Study information

Verified date March 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 31, 2023
Est. primary completion date June 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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".

Study Design


Intervention

Drug:
MethylPREDNISolone 40 Mg/mL Injectable Suspension
intramuscular injection
NaCl 9 MG/ML Injectable Solution
Intramuscular injection

Locations

Country Name City State
Sweden Department of Lung-and Allergy Research Lund Skane

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
3 weeks
Primary Mean symptom score Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms) 3 weeks
Secondary 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)
3 weeks
Secondary 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)
3 weeks
Secondary 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)
3 weeks
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