Allergic AsthmaPhase 2NCT00622362
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
A Phase 2 study testing DEPIGOID Dermatophagoides pteronyssinus and Polymerized TOL of Dermatophagoides pteronyssinus in people with Allergic Asthma, run by Laboratorios Leti, S.L. at 1 site in Spain.
Trial summary
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- DEPIGOID Dermatophagoides pteronyssinus and Polymerized TOL of Dermatophagoides pteronyssinus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Feb 2009
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent signed by the patient and guardian.
- Positive clinical history of allergy to dust mites.
- FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
- Age-between 5 and 14 years.
- Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size > 3 mm diameter and / or RAST (> 0.7 kU / L).
Who cannot join
- Patients out of the age range.
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..).
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
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- Patients suffering from immune deficiencies
- Patients with serious psychiatric / psychological disturbances
- Patients aspirin intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite
Read the detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).
- Conditions
- Allergic Asthma
- Being tested
- DEPIGOID Dermatophagoides pteronyssinus, Polymerized TOL of Dermatophagoides pteronyssinus, Placebo Comparator
- Keywords
- Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEPIGOID Dermatophagoides pteronyssinusBiological
Subcutaneous administration:0.5 ml/month during 1 year
Polymerized TOL of Dermatophagoides pteronyssinusBiological
Sublingual immunotherapy. Two drops daily during 1 year
Placebo ComparatorBiological
Sublingual immunotherapy. Two drops daily during 1 year
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Subcutaneous administration Receives: Biological: DEPIGOID Dermatophagoides pteronyssinus |
| B | Experimental | Sublingual administration Receives: Biological: Polymerized TOL of Dermatophagoides pteronyssinus |
| C | Placebo comparator | Sublingual administration Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and medication scores
Measured: 1 year per patient
Secondary outcomes (6)
Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources
Measured: 1 year per patient
QoL
The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthmaQuestionnaire" E. Juniper
Measured: 1 year
Cost-effectiveness
Measured: 1 year
Dose response prick-test
Measured: 1 year
Inflammatory markers
Measured: 1 year
Use of health resources
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Nieto, MD PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622362
- Sponsor's protocol ID
- 2006-000571-15
- Other IDs
- 101-PG-COM-143
- Status last verified
- Mar 2019
- First submitted
- 10 Jan 2008
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites
- ClinicalTrials.gov ID
- NCT00622362
- Acronym / sponsor ID
- 2006-000571-15
- Conditions
- Allergic Asthma
- Keywords
- Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Jan 2008 (actual)
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 Feb 2008 (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.
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite
Detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Biological: DEPIGOID Dermatophagoides pteronyssinusSubcutaneous administration |
| B | Experimental | Biological: Polymerized TOL of Dermatophagoides pteronyssinusSublingual administration |
| C | Placebo comparator | Biological: Placebo ComparatorSublingual administration |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent signed by the patient and guardian.
- Positive clinical history of allergy to dust mites.
- FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
- Age-between 5 and 14 years.
- Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size > 3 mm diameter and / or RAST (> 0.7 kU / L).
Key exclusion criteria (9 listed)
- Patients out of the age range.
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Patients aspirin intolerance
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 Dermatophagoides pteronyssinusSubcutaneous administration:0.5 ml/month during 1 year | Biological | A |
| Polymerized TOL of Dermatophagoides pteronyssinusSublingual immunotherapy. Two drops daily during 1 year | Biological | B |
| Placebo ComparatorSublingual immunotherapy. Two drops daily during 1 year | Biological | C |
Primary outcome
Symptom and medication scores
Time frame: 1 year per patient
6 secondary outcomes
Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources
Time frame: 1 year per patient
QoL
Time frame: 1 year
Cost-effectiveness
Time frame: 1 year
Dose response prick-test
Time frame: 1 year
Inflammatory markers
Time frame: 1 year
Use of health resources
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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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.
Antonio Nieto, MD PhD principal investigator
1 site 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 Dermatophagoides pteronyssinus and Polymerized TOL of Dermatophagoides pteronyssinus in people with Allergic Asthma, run by Laboratorios Leti, S.L. at 1 site 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 5 inclusion and 9 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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: Lack of recruitment). 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?
Symptom and medication scores (time frame: 1 year per patient). 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 8 Mar 2019.