Rhinitis, Allergic, SeasonalPhase 4NCT04622917
Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.
A Phase 4 study testing MethylPREDNISolone 40 Mg/mL Injectable Suspension and NaCl 9 MG/ML Injectable Solution in people with Rhinitis, Allergic, Seasonal and Hay Fever, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy
- What is being tested?
- MethylPREDNISolone 40 Mg/mL Injectable Suspension and NaCl 9 MG/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 10 Apr 2019to 31 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or nursing.
- Autoimmune or collagen disease.
- Cardiovascular disease.
- Hepatic disease.
- Renal disease.
- Cancer.
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- 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".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- MethylPREDNISolone 40 Mg/mL Injectable Suspension, NaCl 9 MG/ML Injectable Solution
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylPREDNISolone 40 Mg/mL Injectable SuspensionDrug
Also called Depo-Medrol
intramuscular injection
NaCl 9 MG/ML Injectable SolutionDrug
Also called Sodium Chloride
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage Receives: Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension |
| Sodium Chloride (NaCl) | Placebo comparator | NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage Receives: Drug: NaCl 9 MG/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 weeks
Mean symptom score
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
Measured: 3 weeks
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start10 Apr 2019
- Primary completion20 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars Olaf Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622917
- Sponsor's protocol ID
- 791-792
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD of symptoms and use of medication during the trial will be part of the publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
- ClinicalTrials.gov ID
- NCT04622917
- Acronym / sponsor ID
- 791-792
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: MethylPREDNISolone 40 Mg/mL Injectable SuspensionDepo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage |
| Sodium Chloride (NaCl) | Placebo comparator | Drug: NaCl 9 MG/ML Injectable SolutionNaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- Pregnancy or nursing.
- Autoimmune or collagen disease.
- Cardiovascular disease.
- Hepatic disease.
- Renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylPREDNISolone 40 Mg/mL Injectable SuspensionAlso: Depo-Medrolintramuscular injection | Drug | Methylprednisolone |
| NaCl 9 MG/ML Injectable SolutionAlso: Sodium ChlorideIntramuscular injection | Drug | Sodium Chloride (NaCl) |
Primary outcome
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)
Mean symptom score
Time frame: 3 weeks
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
3 secondary outcomes
Effects on Quality of Life (QoL), SNOT
Time frame: 3 weeks
Effects on Quality of Life (QoL), RQLQ
Time frame: 3 weeks
Effects on Quality of Life (QoL), ACQ
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. IPD of symptoms and use of medication during the trial will be part of the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Olaf Cardell, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MethylPREDNISolone 40 Mg/mL Injectable Suspension and NaCl 9 MG/ML Injectable Solution in people with Rhinitis, Allergic, Seasonal and Hay Fever, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Combined Medical- and Symptom score (CSMS) (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.