Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Rhinitis, Allergic, Seasonal; Hay Fever; Pollen Allergy
• Intervention / Treatment: Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension; Drug: NaCl 9 MG/ML Injectable Solution

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22242
      • Department of Lung-and Allergy Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Lars Olaf Cardell, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 791-792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD of symptoms and use of medication during the trial will be part of the publication
• IPD Sharing Time Frame: Publication planed during 2021.
• IPD Sharing Access Criteria: The data was published in Scientific reports (found in supplements) 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No