Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma

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: NCT03394508
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Gunilla Hedlin, Karolinska Institutet

Brief Summary:
The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or Birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".

Condition or disease Intervention/treatment Phase
Rhinitis Asthma Allergy Drug: ALK Alutard birch or 5-grasses Drug: ALK diluent 0,3% human albumin Phase 2 Phase 3

Detailed Description:
26 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma: A Randomized Placebo-controlled Trial
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo
ALK diluent 0,3% human albumin'
Drug: ALK diluent 0,3% human albumin
Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval
Other Name: Human albumin

Experimental: Active treatment
Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension
Drug: ALK Alutard birch or 5-grasses
Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval
Other Name: ALK Alutard birch pollen or ALK Alutard grass pollen




Primary Outcome Measures :
  1. Change in symptoms score after nasal allergen challenge [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.


Secondary Outcome Measures :
  1. Improvement on Visual Analogue Scale (VAS [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Difference in improvement on VAS between active and placebo Group, tha scale ranging from 1 to 10. 1= No improvement, 10= Complete recovery.

  2. Change in skin prick test reactivity [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.

  3. Difference between active and placebo group in Quality of Life [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    5.Difference between active and placebo group in Quality of Life measured using the Juniper Quality of Life Questionnaire

  4. Change in allergen-specific serum immunoglobulin levels. [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    IgE, IgG, IgG4, all values presented as kU/L.

  5. Incidence of adverse events [ Time Frame: 1 hour-1month ]
    Incidence of adverse events graded as mild-moderate-severe

  6. Differences in basophil activation upon in vitro allergenic stimulation. [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Using a basophil activation assay (CD-sens) we will investigate Changes in basophilic reactivity.

  7. Differences in asthma symptom scores [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    The asthma Control test.

  8. Differences in pulmonary function measurement (Spirometry) [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    FEV1

  9. Differences in airway inflammation assessed by exhaled nitric oxide [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Nitric oxide in exhaled air, p.p.b.

  10. Symptom-medication-score [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season

  11. Differences in response to a Bronchial challenge with methacholine [ Time Frame: At inclusion, 12 months after inclusion and 24 months after inclusion for the intervention group. ]
    Methacholine challenge to test the bronchial hyperresponsiveness in the Airways of the included subjects. The subject will inhale increasing doses of methacholine. Spirometry is performed Before and between each inhalation. The cummulative dose of methacholine needed to elicit at 20% decrease in FEV1 (PD20) is reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinitis due to grass or Birch pollen
  • Mild to moderate asthma with a positive methacholine challenge
  • Accepted and signed informed consent.

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 ongoing exposure and 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
  • 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
  • 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
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Gunilla Hedlin, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03394508    
Other Study ID Numbers: DNR 2012/701 EPN Lund
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases