Allergic RhinitisPhase 2NCT01591343
Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml), to Treat Allergic Rhinitis or Rhinoconjunctivitis With or Without Asthma
A Phase 2 study testing Depigoid® (500 DPP/ml) in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 10 sites in Spain.
Trial summary
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis, Rhinoconjunctivitis, Mild Persistent Asthma
- What is being tested?
- Depigoid® (500 DPP/ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 10 sitesSpain
- Study dates
- Jun 2012to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 55 years of age (both inclusive).
- Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose less or equal to 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
- The IgE-mediated sensitization will be demonstrated by means of the following: medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ≥ 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
- Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.
Who cannot join
- Any contraindication for treatment with allergen specific immunotherapy.
- Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value < 80% of the predicted normal value.
- Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia).
- Subjects with typical symptoms to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelial cells cannot participate in this study. Patients sensitized to pollens with specific IgE CAP RAST < 2 can be included in this study provided that they do not present symptoms as a consequence of this sensitization. Patients sensitized to animal epithelia who do not present symptoms can participate in this study provided that they are not exposed to the allergen to which they are sensitized, even though they present specific IgE with CAP RAST ≥ 2. If they were exposed to the animal in question, these subjects must have a specific IgE with CAP RAST < 2 in order to participate in the study.
- Asthma requiring a dose > 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010).
- Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
Show all 31Show fewer
- Patients with asthma who have been treated with systemic steroids within 3 months prior to V1.
- Patients with hospital admission due to asthma exacerbations within 1 year prior to V1
- Acute or chronic inflammatory or infectious diseases of the airways.
- Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
- Immune system diseases, both autoimmune diseases and immunodeficiency.
- Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
- Serious uncontrolled diseases involving a risk for the subjects participating in this study, including the following for example: heart failure, serious or uncontrolled respiratory diseases, endocrine diseases, clinically relevant liver or kidney diseases or hematological diseases.
- Malignant disease with activity in the last 5 years.
- Clinically significant anomaly in laboratory parameters or vital signs which could involve a risk increase for the subject.
- Excessive consumption of alcohol, drugs or medication in the preceding year.
- Serious psychiatric, psychological or neurological disorders.
- Use of immunotherapy with allergenic extracts of storage or house dust mites in the last 5 years.
- Systemic or topical treatment with beta-blocker drugs.
- Treatment with substances interfering with the immune system 2 weeks before visit 2.
- Use of psychotropic or antidepressants substances.
- Use of systemic corticosteroids 3 months before visit 1.
- Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 2. (Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later).
- Participation of the subject in another clinical trial 30 days before visit 2.
- Subjects who have already participated in this clinical trial.
- Subjects who are going to donate stem cells, blood, organs or bone marrow in the course of the study.
- Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or 2.
- Women of childbearing potential not using highly effective methods of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- No written informed consent upon enrolment.
- Not willing to give consent for transmission of personal "pseudonymised" data.
- Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Complejo Hospitalario Torrecárdenas
Almería, Andalusia, 04009
Al·lergo Centre
Barcelona, Catalonia, 08021
Centro Médico Teknon
Barcelona, Catalonia, 08022
Hospital Universitario Vall d'Hebrón
Barcelona, Catalonia, 08035
Hospital Universitario de Bellvitge
Barcelona, Catalonia, 08907
Clínica Doctor Lobatón
Cadiz, Andalusia, 11008
Complejo Hospitalario Universitario de Cartagena
Cartagena, Murcia, 03020
Hospita Universitario Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Joan XXIII
Tarragona, Catalonia, 43007
About this study
Official title: Prospective Study to Evaluate the Safety of a 4-month Treatment With Depigoid® Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml) in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Mild Persistent or Intermittent Asthma
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma.
Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Read the detailed description
Investigator(s):
Approximately 10 study centers (allergy services) in Spain
Planned study period:
MAY 2012 (first subject in) - MAR 2013 (last subject out)
Objectives:
Primary objective: to evaluate the safety of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen.
Secondary objective: to assess the subjects' immunologic responses to the above treatment.
Study design:
This is a prospective, non-randomized, uncontrolled, open-label safety study. When the first 29 subjects have completed the study, an interim analysis will be conducted to check whether the number of systemic reactions in these subjects is below a predefined limit.
Planned number of subjects:
103 subjects in total.
Medical condition or disease under investigation:
Allergic rhinitis or rhinoconjunctivitis, with or without mild persistent or intermittent asthma.
Test product, dose and mode of administration:
Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml).
Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection
Duration of treatment:
16 weeks.
Criteria for evaluation:
Safety:
Local and systemic adverse reactions (EAACI classification); adverse events.
Efficacy:
Immunologic response to the treatment.
Statistical methods:
Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Analysis of primary variable: exact binomial test
- Being tested
- Depigoid® (500 DPP/ml)
- Keywords
- Specific immunotherapy, Allergic rhinitis, Allergic rhinoconjunctivitis, Asthma
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depigoid® (500 DPP/ml)Biological
Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml).
Dose:
Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Depigoid® (500 DPP/ml) | Experimental | Patients will receive either Depigoid® Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), depending on their sensitization to one or both mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae). Receives: Biological: Depigoid® (500 DPP/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary variable
Number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Measured: 4 months
Secondary outcomes (1)
Secondary variables
Secondary variables, which will be analyzed descriptively, are the
- Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
- Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm or > 10 cm).
- Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
- Number of immediate and/or or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm and > 10 cm).
- Immunologic response to the treatment.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Study halted by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harrison Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591343
- Sponsor's protocol ID
- 101-PG-PSC-186
- Status last verified
- Feb 2018
- First submitted
- 2 May 2012
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Safety of a 4-month Treatment With Depigoid® Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml) in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Mild Persistent or Intermittent Asthma
- ClinicalTrials.gov ID
- NCT01591343
- Acronym / sponsor ID
- 101-PG-PSC-186
- Keywords
- Specific immunotherapy, Allergic rhinitis, Allergic rhinoconjunctivitis, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted by Sponsor
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Collaborators
- Harrison Clinical Research
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma.
Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Detailed description
Investigator(s):
Approximately 10 study centers (allergy services) in Spain
Planned study period:
MAY 2012 (first subject in) - MAR 2013 (last subject out)
Objectives:
Primary objective: to evaluate the safety of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen.
Secondary objective: to assess the subjects' immunologic responses to the above treatment.
Study design:
This is a prospective, non-randomized, uncontrolled, open-label safety study. When the first 29 subjects have completed the study, an interim analysis will be conducted to check whether the number of systemic reactions in these subjects is below a predefined limit.
Planned number of subjects:
103 subjects in total.
Medical condition or disease under investigation:
Allergic rhinitis or rhinoconjunctivitis, with or without mild persistent or intermittent asthma.
Test product, dose and mode of administration:
Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml).
Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection
Duration of treatment:
16 weeks.
Criteria for evaluation:
Safety:
Local and systemic adverse reactions (EAACI classification); adverse events.
Efficacy:
Immunologic response to the treatment.
Statistical methods:
Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Analysis of primary variable: exact binomial test
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depigoid® (500 DPP/ml) | Experimental | Biological: Depigoid® (500 DPP/ml)Patients will receive either Depigoid® Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), depending on their sensitization to one or both mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 55 years of age (both inclusive).
- Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose less or equal to 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
- The IgE-mediated sensitization will be demonstrated by means of the following: medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ≥ 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
- Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.
Key exclusion criteria (31 listed)
- Any contraindication for treatment with allergen specific immunotherapy.
- Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value < 80% of the predicted normal value.
- Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia).
- Subjects with typical symptoms to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelial cells cannot participate in this study. Patients sensitized to pollens with specific IgE CAP RAST < 2 can be included in this study provided that they do not present symptoms as a consequence of this sensitization. Patients sensitized to animal epithelia who do not present symptoms can participate in this study provided that they are not exposed to the allergen to which they are sensitized, even though they present specific IgE with CAP RAST ≥ 2. If they were exposed to the animal in question, these subjects must have a specific IgE with CAP RAST < 2 in order to participate in the study.
- Asthma requiring a dose > 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depigoid® (500 DPP/ml)Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection | Biological | Depigoid® (500 DPP/ml) |
Primary outcome
Primary variable
Time frame: 4 months
Number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
1 secondary outcome
Secondary variables
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Study halted by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depigoid® (500 DPP/ml) in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary variable (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.