ClinicalTrials.gov
ClinicalTrials.gov Menu

Intralymphatic Immunotherapy in Increasing Doses, Substudy

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: NCT02975479
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
Skane University Hospital
Karolinska University 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 with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.


Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: ALK Diluent Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch Phase 2 Phase 3

Detailed Description:
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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. Substudy.
Study Start Date : May 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Placebo Comparator: Intralymphatic placebo injections
ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval.
Drug: ALK Diluent
Other Name: 0,3% human albumin. ATC-code V07AB

Active Comparator: Intralymphatic active injections

ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U.

***IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. ***

Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
Other Name: Allergen, grass pollen. ATC-code V01AA02 or V01AA05




Primary Outcome Measures :
  1. Mean combined daily symptoms-and-medications-score [ Time Frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). ]
    Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).


Secondary Outcome Measures :
  1. Mean total daily symptoms score [ Time Frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). ]
    Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)

  2. Mean total daily medications score [ Time Frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment). ]
    Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).

  3. Change in subjective allergic symptoms following nasal allergen provocation [ Time Frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. ]
    The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.

  4. Effects on quality of life [ Time Frame: During peak pollen season which will be up to 6 months after completed treatment. ]
    Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires

  5. Short term change of skin reactivity [ Time Frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. ]
    Skin prick test

  6. S-IgE Grass or Birch [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]
  7. S-IgG4 Grass or Birch [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]
  8. Registration of adverse event [ Time Frame: From the first injection to 30 days after the last injections has been given ]


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.


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

Inclusion Criteria:

  • 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 β-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

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): NCT02975479


Locations
Sweden
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
Lund, Sweden, 221 85
ENT-department, Karolinska University Hospital Huddinge (ENT-department B51)
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Skane University Hospital
Karolinska University Hospital
Investigators
Principal Investigator: Lars-Olaf Cardell, Professor Karolinska Institutet

Responsible Party: Lars Olaf Cardell, Professor, Head of Division, M.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02975479     History of Changes
Other Study ID Numbers: 2015-001259-63 substudy
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lars Olaf Cardell, Karolinska Institutet:
Hay fever
Pollen allergy
Allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases