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SUBLIVAC FIX Mite Mixture Dose Tolerability Study (DTS)

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ClinicalTrials.gov Identifier: NCT02345278
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
HAL Allergy

Brief Summary:

Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.

According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.


Condition or disease Intervention/treatment Phase
House Dust Mite Allergy Drug: SUBLIVAC FIX Mite mixture Other: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
once daily sublingual administration for 1 month
Other: Placebo
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Active Comparator: SUBLIVAC FIX Mite mixture 10,000 AU/mL
once daily sublingual administration for 1 month
Drug: SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Active Comparator: SUBLIVAC FIX Mite mixture 25,000 AU/mL
once daily sublingual administration for 1 month
Drug: SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Active Comparator: SUBLIVAC FIX Mite mixture 50,000 AU/mL
once daily sublingual administration for 1 month
Drug: SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Active Comparator: SUBLIVAC FIX Mite mixture 100,000 AU/mL
once daily sublingual administration for 1 month
Drug: SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.




Primary Outcome Measures :
  1. Safety and tolerability of SUBLIVAC FIX Mite mixture (assessed by number and severity of local and systemic reactions) [ Time Frame: 1 month treatment ]
    Safety and tolerability of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of local and systemic reactions.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 month treatment ]
    Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by number and severity of Adverse Events

  2. Clinical and laboratory parameters (Safety of different dosages of SUBLIVAC FIX Mite mixture) [ Time Frame: 1 month treatment ]
    Safety of different dosages of SUBLIVAC FIX Mite mixture compared to placebo assessed by clinical and laboratory parameters

  3. Changes in immunoglobulin levels ((IgE, IgG, IgG4) [ Time Frame: 1 month ]
    Changes in serum specific immunoglobulin levels (IgE, IgG, IgG4) after 1 month of treatment with different dosages of SUBLIVAC FIX Mite mixture compared to placebo

  4. Proportion of patients reaching maintenance dose within 10 days [ Time Frame: 10 days ]
    Proportions of patients in the different treatment groups reaching maintenance dose within 10 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Male or female patients, age ≥ 18 ≤ 60 years
  3. Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma
  4. Patients with a history of concomitant asthma should have a FEV1 > 70% (of predicted value) at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80% (of predicted value)
  5. Positive SPT to HDM D. pter or D. far (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) at screening
  6. Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (> 0.7 U/ml), assessed at screening

Exclusion Criteria:

  1. Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) who are expected to have clinically relevant symptoms during the treatment period
  2. Patients sensitized and symptomatic to pets who are regularly exposed to pets
  3. Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
  4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
  5. Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
  6. Any other vaccination one week before start of treatment and during the up-dosing phase
  7. Any anti-IgE therapy within the last 6 months prior to inclusion and during study
  8. Active inflammatory disease in the mouth (e.g periodontitis, oral mucosal lichen planus)
  9. Known hypersensitivity to any of the excipients (i.e. Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Aminocaproic acid, Glycerol, Peppermint oil, Caramel Colorant) of SLIT solution
  10. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
  11. Active malignancies or any malignant disease in the last 5 years
  12. A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
  13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
  14. Use of systemic corticosteroids 4 weeks before start treatment
  15. Treatment with systemic or local beta-blockers
  16. Clinically significant chronic sinusitis or ocular infection
  17. Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study
  18. Pregnancy, lactation or inadequate contraceptive measures (acceptable forms of birth control include Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or condom combined with a diaphragm including spermicidal cream). Also acceptable for women is surgical sterilization (removal of the uterus or ovaries or tubal ligation ("tied tubes")), if they are postmenopausal (12 consecutive months without a period) for at least 2 years, or having no sexual relationship with a man.
  19. Alcohol, drug, or medication abuse within the past year and during the study
  20. Any lack of co-operation or compliance
  21. Severe psychiatric, psychological, or neurological disorders
  22. Patients who are employees of the department or study site; 1st grade relatives, partners of the investigator, or patients who are dependent on the sponsor
  23. Any physical or mental condition that precludes administration of allergen-specific immunotherapy, compliance or participation in a trial
  24. Patients who are placed in an institution due to governmental or judicial directive

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): NCT02345278


Locations
Germany
Charite Universitatsmedizin Berlin, Allergiezentrum
Berlin, Germany, D-10117
Praxis Dr.med.Elke Hippke
Berlin, Germany, D-13057
HNO-Heilkunde Praxis
Chemnitz, Germany, D-09130
HNO und Allergologie Praxis
Dresden, Germany, D-01139
HNO-Praxis Dr. Uta Thieme
Duisburg, Germany, D-47051
Universitatsklinikum Dusseldorf, Department Dermatology
Dusseldorf, Germany, D-40225
HNO Praxis Gottingen
Gottingen, Germany, D-37073
HNO Praxis am Neckar
Heidelberg, Germany, D-69120
HNO Gemeinschaftspraxis
Heidelberg, Germany, D-69126
Dr.med. Ulrich Neumann Praxis
Wolmirstedt, Germany, D-39326
Sponsors and Collaborators
HAL Allergy
Investigators
Study Chair: Margitta Worm, Prof.Dr.med. Allergie-Centrum-Charité

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT02345278     History of Changes
Other Study ID Numbers: SM/0044
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by HAL Allergy:
Immunotherapy
Allergic rhinitis/rhinoconjunctivitis