Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Sponsor

Karolinska Institutet (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04622917

Collaborator

(none)

Enrollment

Location

Arms

49.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal Hay Fever Pollen Allergy Allergic Rhinitis	Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension Drug: NaCl 9 MG/ML Injectable Solution	Phase 4

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

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2019

Actual Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Methylprednisolone

Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage

Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

intramuscular injection

Other Names:

Depo-Medrol

Placebo Comparator: Sodium Chloride (NaCl)

NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage

Drug: NaCl 9 MG/ML Injectable Solution

Intramuscular injection

Other Names:

Sodium Chloride

Outcome Measures

Primary Outcome Measures

Mean Combined Medical- and Symptom score (CSMS) [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 [3 weeks]
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)

Secondary Outcome Measures

Effects on Quality of Life (QoL), SNOT [3 weeks]
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)
Effects on Quality of Life (QoL), RQLQ [3 weeks]
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)
Effects on Quality of Life (QoL), ACQ [3 weeks]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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.
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".