Allergic RhinitisPhase 1/2NCT04296474
Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
A Phase 1/2 study testing ALK Alutard 5-grasses and birch and ALK Diluent in people with Allergic Rhinitis, run by Lars Olaf Cardell at 3 sites in Sweden.
Trial summary
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ALK Alutard 5-grasses and birch and ALK Diluent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesSweden
- Study dates
- 15 May 2018to 1 Jul 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies
Who cannot join
- uncontrolled or perennial asthma
- other pulmonary disease
- known autoimmune or collagen disease
- chronic infection
- other significant disease
- severe atopic dermatitis
Show all 13Show fewer
- use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
- symptomatic sensitization to house dust mite or furry animals with daily exposure
- chronic upper airways disease
- pregnancy
- nursing
- obesity with BMI >30
- withdrawn informed consent
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
Lund, 221 85
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö
Malmö, 20502
ENT department, Karolinska University Hospital
Stockholm, 141 86
About this study
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.
Read the detailed description
Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.
Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.
Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.
- Conditions
- Allergic Rhinitis
- Being tested
- ALK Alutard 5-grasses and birch, ALK Diluent
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK Alutard 5-grasses and birchDrug
Also called Grass and birch allergen with aluminum adjuvant
Intralymphatic injections
ALK DiluentDrug
Also called Human albumin
intralymphatic injections
| Study group | Role | What they receive |
|---|---|---|
| Active ILIT treated | Active comparator | Patients that have received ILIT with birch and grass allergen 5-6 years previously Receives: Drug: ALK Alutard 5-grasses and birch |
| Non- AIT treated | Placebo comparator | Patients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT). Receives: Drug: ALK Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal grass allergen provocation
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Measured: 5-6 years after active or placebo ILIT
Secondary outcomes (7)
Nasal birch allergen provocation
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
Measured: 5-6 years after active or placebo ILIT
Combined symptoms and medciations score
Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication.
Measured: Pollen season 5-7 years after active or placebo ILIT
Rhinoconjunctivitis quality of life questionnaire
Average score of 28 questions ranging from 0-no impairment of quality of life, to 6- maximum impairment of quality of life.
Measured: Pollen season 5-7 years after active or placebo ILIT
Sinonasal outcome test quality of life questionnaire
Sum of 22 questions. The score ranges from 0-no impairment of quality of life, to 110- maximum impairment of quality of life.
Measured: Pollen season 5-7 years after active or placebo ILIT
Allergen specific IgE
Blood test
Measured: 5-6 years after active or placebo ILIT
Allergen specific IgG4
Blood test
Measured: 5-6 years after active or placebo ILIT
T-cell and basophil activation
Blood samples and lymph node aspirates are investigated with flow cytometry
Measured: 5-6 years after active or placebo ILIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start15 May 2018
- Primary completion20 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Olaf Cardell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars Olaf Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296474
- Sponsor's protocol ID
- Follow-up ILIT 2018/2645-32
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hellkvist L, Hjalmarsson E, Kumlien Georen S, Karlsson A, Lundkvist K, Winqvist O, Westin U, Cardell LO. Intralymphatic immunotherapy with 2 concomitant allergens, birch and grass: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2018 Oct;142(4):1338-1341.e9. doi: 10.1016/j.jaci.2018.05.030. Epub 2018 Jun 13. No abstract available.
PubMed 29908212
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
- ClinicalTrials.gov ID
- NCT04296474
- Acronym / sponsor ID
- Follow-up ILIT 2018/2645-32
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lars Olaf CardellUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Mar 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.
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.
Detailed description
Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.
Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.
Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ILIT treated | Active comparator | Drug: ALK Alutard 5-grasses and birchPatients that have received ILIT with birch and grass allergen 5-6 years previously |
| Non- AIT treated | Placebo comparator | Drug: ALK DiluentPatients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies
Key exclusion criteria (13 listed)
- uncontrolled or perennial asthma
- other pulmonary disease
- known autoimmune or collagen disease
- chronic infection
- other significant 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 |
|---|---|---|
| ALK Alutard 5-grasses and birchAlso: Grass and birch allergen with aluminum adjuvantIntralymphatic injections | Drug | Active ILIT treated |
| ALK DiluentAlso: Human albuminintralymphatic injections | Drug | Non- AIT treated |
Primary outcome
Nasal grass allergen provocation
Time frame: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
7 secondary outcomes
Nasal birch allergen provocation
Time frame: 5-6 years after active or placebo ILIT
Combined symptoms and medciations score
Time frame: Pollen season 5-7 years after active or placebo ILIT
Rhinoconjunctivitis quality of life questionnaire
Time frame: Pollen season 5-7 years after active or placebo ILIT
Sinonasal outcome test quality of life questionnaire
Time frame: Pollen season 5-7 years after active or placebo ILIT
Allergen specific IgE
Time frame: 5-6 years after active or placebo ILIT
Allergen specific IgG4
Time frame: 5-6 years after active or placebo ILIT
T-cell and basophil activation
Time frame: 5-6 years after active or placebo ILIT
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 21 Sep 2022.
- Background: PubMed 29908212Hellkvist L, Hjalmarsson E, Kumlien Georen S, Karlsson A, Lundkvist K, Winqvist O, Westin U, Cardell LO. Intralymphatic immunotherapy with 2 concomitant allergens, birch and grass: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2018 Oct;142(4):1338-1341.e9. doi: 10.1016/j.jaci.2018.05.030. Epub 2018 Jun 13. No abstract available.
- Individual participant dataSharing planned: No
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALK Alutard 5-grasses and birch and ALK Diluent in people with Allergic Rhinitis, run by Lars Olaf Cardell at 3 sites 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 1 inclusion and 13 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Nasal grass allergen provocation (time frame: 5-6 years after active or placebo ILIT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296474, which also lists 1 linked publication.
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 21 Sep 2022.