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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04210193
Other study ID # ILIT Borås EPN 2014/251
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 25, 2014
Est. completion date December 1, 2019

Study information

Verified date December 2019
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.


Description:

The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.

The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.

The first part of the study is completed and published (PMID: 23374268)


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Age 18-50,

- Seasonal allergic symptoms for birch and/or grass verified by skin prick test,

- Accepted informed consent

Exclusion Criteria:

- Pregnancy or nursing

- Autoimmune or collagen disease (known)

- Cardiovascular disease

- Perennial pulmonary disease

- Hepatic disease

- Renal disease

- Cancer

- Any medication with a possible side-effect of interfering with the immune response

- Previous immuno- or chemotherapy

- Chronic diseases

- Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)

- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers)

- Major metabolic disease

- Known or suspected allergy to the study product

- Alcohol or drug abuse

- Mental incapability of coping with the study

- Withdrawal of informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ALK Alutard 5-grasses
0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
ALK Diluent
0.1 mL of ALK Diluent as an intralymphatic injection

Locations

Country Name City State
Sweden Allergy Unit, Södra Älvsborgs Hospital Borås

Sponsors (1)

Lead Sponsor Collaborator
Lars Olaf Cardell

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georén S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9. — View Citation

Konradsen JR, Grundström J, Hellkvist L, Thu Tran TA, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen allergic young adults with rhinoconjunctivitis and mild asthma: a randomized trial. J Allergy Clin Immunol. 2019 Nov 24. pii: S0091-6749(19)31599-4. doi: 10.1016/j.jaci.2019.11.017. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the serum-level of timothy specific IgG4 after 1 month Blood samples with measurement of allergen specific blocking IgG4 antibodies Change between baseline and 1 month after treatment.
Primary Change in the serum-level of timothy specific IgG4 after 9 months Blood samples with measurement of allergen specific blocking IgG4 antibodies Change between baseline and 9 months after treatment.
Primary Change in the serum-level of timothy specific IgG4 2 months after booster Blood samples with measurement of allergen specific blocking IgG4 antibodies Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Primary Change in the serum-level of timothy specific IgG4 10 months after booster Blood samples with measurement of allergen specific blocking IgG4 antibodies Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
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