Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622917
• Other study ID #: 791-792
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2023
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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".

Related Conditions & MeSH terms

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

Intervention

Drug:
• MethylPREDNISolone 40 Mg/mL Injectable Suspension
intramuscular injection
• NaCl 9 MG/ML Injectable Solution
Intramuscular injection

Locations

Country	Name	City	State
Sweden	Department of Lung-and Allergy Research	Lund	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean symptom score	Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)	3 weeks
Secondary	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
Secondary	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
Secondary	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