Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

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

Detailed Description
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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.

Official Title
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Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect

Conditions
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Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Allergic Rhinitis

Intervention / Treatment
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* Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension
* Drug: NaCl 9 MG/ML Injectable Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage | Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension<br>* intramuscular injection<br>* Other names: Depo-Medrol;|
| Placebo Comparator: Sodium Chloride (NaCl)<br>NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage | Drug: NaCl 9 MG/ML Injectable Solution<br>* Intramuscular injection<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mean symptom score | Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |