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Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Primary Purpose

Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy

Status
Active
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
MethylPREDNISolone 40 Mg/mL Injectable Suspension
NaCl 9 MG/ML Injectable Solution
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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".

Sites / Locations

  • Department of Lung-and Allergy Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolone

Sodium Chloride (NaCl)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
Mean symptom score
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
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
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
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)

Full Information

First Posted
October 22, 2020
Last Updated
June 22, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04622917
Brief Title
Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.
Official Title
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage
Arm Title
Sodium Chloride (NaCl)
Arm Type
Placebo Comparator
Arm Description
NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage
Intervention Type
Drug
Intervention Name(s)
MethylPREDNISolone 40 Mg/mL Injectable Suspension
Other Intervention Name(s)
Depo-Medrol
Intervention Description
intramuscular injection
Intervention Type
Drug
Intervention Name(s)
NaCl 9 MG/ML Injectable Solution
Other Intervention Name(s)
Sodium Chloride
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Mean Combined Medical- and Symptom score (CSMS)
Description
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)
Time Frame
3 weeks
Title
Mean symptom score
Description
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Effects on Quality of Life (QoL), SNOT
Description
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)
Time Frame
3 weeks
Title
Effects on Quality of Life (QoL), RQLQ
Description
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)
Time Frame
3 weeks
Title
Effects on Quality of Life (QoL), ACQ
Description
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)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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".
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Olaf Cardell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Lung-and Allergy Research
City
Lund
State/Province
Skane
ZIP/Postal Code
22242
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

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