Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Mean Combined Medical- and Symptom score (CSMS)
Study Overview
Brief Summary
This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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".
Arms & Interventions
Methylprednisolone
Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage
Intervention: MethylPREDNISolone 40 Mg/mL Injectable Suspension (Drug)
Sodium Chloride (NaCl)
NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage
Intervention: NaCl 9 MG/ML Injectable Solution (Drug)
Outcomes
Primary Outcomes
Mean Combined Medical- and Symptom score (CSMS)
Time Frame: 3 weeks
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)
Mean symptom score
Time Frame: 3 weeks
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
Secondary Outcomes
- Effects on Quality of Life (QoL), SNOT(3 weeks)
- Effects on Quality of Life (QoL), RQLQ(3 weeks)
- Effects on Quality of Life (QoL), ACQ(3 weeks)
Investigators
Lars Olaf Cardell
Professor, MD
Karolinska Institutet