Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

NCT04622917 | Completed Phase 4

• 1 other identifier: 791-792
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

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

Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

Sodium Chloride (NaCl)

PLACEBO COMPARATOR

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

Drug: NaCl 9 MG/ML Injectable Solution

Interventions

MethylPREDNISolone 40 Mg/mL Injectable Suspension DRUG

intramuscular injection

Also known as: Depo-Medrol

Methylprednisolone

NaCl 9 MG/ML Injectable Solution DRUG

Intramuscular injection

Also known as: Sodium Chloride

Sodium Chloride (NaCl)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Lung-and Allergy Research

Lund, Skåne County, 22242, Sweden

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Interventions

Methylprednisolone; Methylprednisolone Acetate; Sodium Chloride

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lars Olaf Cardell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 10, 2020
• Study Start: April 10, 2019
• Primary Completion: June 20, 2022
• Study Completion: May 31, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Publication planed during 2021.
• Access Criteria: The data was published in Scientific reports (found in supplements) 2023

Locations

SE (1)