Allergic RhinoconjunctivitisPhase 1NCT01489020
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
A Phase 1 study testing subcutaneous immunotherapy with DPT extract in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 2 sites in Spain.
Trial summary
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- subcutaneous immunotherapy with DPT extract
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.
- Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.
- Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
- Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active
Who cannot join
- Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- Patients with a previous history of anaphylaxis
Show all 18Show fewer
- Patients with chronic urticaria
- Patients with unstable angina
- Patients with uncontrolled hypertension
- Patients with clinically significant arrythmias
- Patients with neoplasia
- Patients with clinically relevant malformations of the upper respiratory tract.
- Other chronic or immunological disease that could interfere with the assessment of the investigational product or that could generate any additional risk for the patients
- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilised or present any other incapacity to bear
- Patient who does not attend the visits
- Patient's lack of collaboration or refusal to participate
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital La Fe
Valencia, 46009
About this study
Official title: Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- subcutaneous immunotherapy with DPT extract, Subcutaneous depot placebo
- Keywords
- Allergy, Immunotherapy, Allergic Rhinoconjunctivitis, D. pteronyssinus, house dust allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous immunotherapy with DPT extractBiological
Also called DPT depot vaccine
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
Subcutaneous depot placeboBiological
Increasing doses of subcutaneous depot placebo in three different scales
| Study group | Role | What they receive |
|---|---|---|
| Group A active | Experimental | 6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. Receives: Biological: subcutaneous immunotherapy with DPT extract |
| Group A placebo | Placebo comparator | 6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. Receives: Biological: Subcutaneous depot placebo |
| group B active | Experimental | 8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals Receives: Biological: subcutaneous immunotherapy with DPT extract |
| Group B placebo | Placebo comparator | 8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals Receives: Biological: Subcutaneous depot placebo |
| Group C active | Experimental | 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval Receives: Biological: subcutaneous immunotherapy with DPT extract |
| Group C placebo | Placebo comparator | 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval Receives: Biological: Subcutaneous depot placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Seriousness of Both Local and Systemic Adverse Reactions
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
Measured: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Secondary outcomes (3)
Immunoglobulin Levels (IgE Specific) Active Versus Placebo
Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Measured: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG Total) Active Versus Placebo
Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Measured: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG 4) Active Versus Placebo
Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Measured: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinoconjunctivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mª Dolores Hernández, MD, Principal investigator, Hospital Universitario La FeIgnacio Antépara, MD, Principal investigator, Hospital de Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489020
- Sponsor's protocol ID
- BIA-DPT-P1-001
- Other IDs
- 2009-016277-15, 2009
- Status last verified
- Jan 2019
- First submitted
- 2 Dec 2011
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.
- ClinicalTrials.gov ID
- NCT01489020
- Acronym / sponsor ID
- BIA-DPT-P1-001
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergy, Immunotherapy, Allergic Rhinoconjunctivitis, D. pteronyssinus, house dust allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A active | Experimental | Biological: subcutaneous immunotherapy with DPT extract6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. |
| Group A placebo | Placebo comparator | Biological: Subcutaneous depot placebo6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. |
| group B active | Experimental | Biological: subcutaneous immunotherapy with DPT extract8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals |
| Group B placebo | Placebo comparator | Biological: Subcutaneous depot placebo8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals |
| Group C active | Experimental | Biological: subcutaneous immunotherapy with DPT extract8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval |
| Group C placebo | Placebo comparator | Biological: Subcutaneous depot placebo8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.
- Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.
Key exclusion criteria (18 listed)
- Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
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 |
|---|---|---|
| subcutaneous immunotherapy with DPT extractAlso: DPT depot vaccineIncreasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) | Biological | Group A active, Group C active, group B active |
| Subcutaneous depot placeboIncreasing doses of subcutaneous depot placebo in three different scales | Biological | Group A placebo, Group B placebo, Group C placebo |
Primary outcome
Number and Seriousness of Both Local and Systemic Adverse Reactions
Time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
3 secondary outcomes
Immunoglobulin Levels (IgE Specific) Active Versus Placebo
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG Total) Active Versus Placebo
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG 4) Active Versus Placebo
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mª Dolores Hernández, MD principal investigator
Hospital Universitario La Fe
Ignacio Antépara, MD principal investigator
Hospital de Basurto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing subcutaneous immunotherapy with DPT extract in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 2 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Seriousness of Both Local and Systemic Adverse Reactions (time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )). 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 6 May 2019.