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Completed

NCT Number: NCT04622917

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

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

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Key information

Conditions

Rhinitis, Allergic, Seasonal Allergic Rhinitis Hay Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Pollen Allergy Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Lung-and Allergy Research

Lund, Skåne County, 22242, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

MethylPREDNISolone 40 Mg/mL Injectable Suspension

Drug

intramuscular injection

Other names: Depo-Medrol

NaCl 9 MG/ML Injectable Solution

Drug

Intramuscular injection

Other names: Sodium Chloride

Primary outcomes

  1. 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)

  2. 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

  1. Effects on Quality of Life (QoL), SNOT

    Time frame: 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)

  2. Effects on Quality of Life (QoL), RQLQ

    Time frame: 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)

  3. Effects on Quality of Life (QoL), ACQ

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 10, 2020
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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