Allergic Rhinitis Clinical Trial
Official title:
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
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 |
Verified date | March 2024 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.
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". |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Lung-and Allergy Research | Lund | Skane |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
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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