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Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679105
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Karolinska University Hospital
Skane University Hospital
Sodra Alvsborgs Hospital
Information provided by (Responsible Party):
Lars Olaf Cardell, Karolinska Institutet

Brief Summary:
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic Drug: ALK Alutard birch or 5-grasses Drug: ALK diluent Phase 2 Phase 3

Detailed Description:
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : March 2019

Arm Intervention/treatment
Placebo Comparator: ALK diluent
Human albumin
Drug: ALK diluent
0,3% human albumin
Other Name: Human albumin

Active Comparator: ALK Alutard birch or 5-grasses
Grass pollen suspension or birch pollen suspension
Drug: ALK Alutard birch or 5-grasses
3 injections with 4-5 weeks interval.
Other Names:
  • ALK Alutard birch pollen or ALK Alutard grass pollen
  • ATC-code V01AA, V04CL and V07AB




Primary Outcome Measures :
  1. Total daily symptoms and medications score [ Time Frame: 5-7 months after treatment ]
    Difference between active and placebo group in total daily symptoms and medications score during the pollen season.


Secondary Outcome Measures :
  1. Improvement on Visual Analogue Scale (VAS) [ Time Frame: During pollen season and recalled after pollen season, approximately 1 year after the start of treatment. ]
    Difference in improvement on VAS between active and placebo group.

  2. Change in skin prick test reactivity [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]
    Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.

  3. Change in symptoms score after nasal allergen challenge [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]
    0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.

  4. Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: Up to 7 months after treatment. ]
    At peak pollen season after treatment.

  5. Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22) [ Time Frame: Up to 7 months after treatment. ]
    At peak pollen season after treatment.

  6. Change in allergen specific S- antibody levels. [ Time Frame: 4-8 weeks after treatment, 9-12 months after treatment ]
    IgE, IgG, IgG4

  7. Incidence of adverse events graded as mild-moderate-severe [ Time Frame: From first injection to 30 days after last injection. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-55
  • Accepted and signed informed consent.
  • Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.

Exclusion Criteria:

  • Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
  • Previously SCIT but no symptom improvement at all.
  • Sensitizations to house dust mite or furry animals, with symptoms.
  • Severe atopic dermatitis.
  • Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  • Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
  • Known autoimmune or collagen disease
  • Cardiovascular disease
  • Perennial pulmonary disease including asthma
  • Hepatic disease
  • Known renal insufficiency
  • Cancer
  • Hematologic disease
  • Chronic infectious disease
  • Any medication with a possible side-effect of interfering with the immune response
  • Previous immuno- or chemotherapy, apart from SCIT
  • Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
  • Major metabolic disease
  • Known or suspected allergy to the study product
  • Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
  • Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
  • Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
  • Mental incapability of coping with the study
  • Withdrawal of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679105


Locations
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Sweden
Allergy Unit, Södra Älvsborgs Hospital
Borås, Sweden, 501 82
ENT department, Skånes University Hospital Malmö and Lund
Malmö, Sweden, 205 02
ENT department, Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Skane University Hospital
Sodra Alvsborgs Hospital
Investigators
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Principal Investigator: Lars Olaf Cardell, Professor Karolinska University Hospital
Publications of Results:
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Responsible Party: Lars Olaf Cardell, Professor, Head of Division, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02679105    
Other Study ID Numbers: 2015-001259-63
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases