Allergic RhinoconjunctivitisPhase 3NCT00916760
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
A Phase 3 study testing Depigoid Parietaria judaica 1000DPP/ml in people with Allergic Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 11 sites in Spain.
Trial summary
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Depigoid Parietaria judaica 1000DPP/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 11 sitesSpain
- Study dates
- Feb 2008to Feb 2013
- Phase
- Phase 3
- 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
- Informed consent, signed by the subject
- Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
- Patient of both gender aged from 18 up to 55
- Diagnosed Sensitivity to Parietaria pollen base on:
- Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L
- Patients who are able to comply with the dose regime
Who cannot join
- Relevant sensitivity to another perenne allergen
- Patient with asthma
- Use of immunotherapy during the last four years
- Treatment with B. Blocking agents
- Patient suffering from some pathology in which adrenaline was contraindicated
- Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
Show all 10Show fewer
- Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
- Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance.
- Intolerance to aspirin
- Pregnant women or with pregnancy risk and brest-feeding
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Vega Baja
Alicante, Orihuela, 03314
Hospital Marina Baixa
Alicante
H. Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Viladecans
Barcelona, Barcelona, 08840
Hospital de Castellón
Castellon
Hospital Reina Sofía
Murcia
Hospital Virgen de la Arrixaca
Murcia
Hospital General de Onteniente
Ontinyent, Valencia
H. de sagunto
Sagunto, Sagunto, 46520
Hospital La Fe
Valencia
Hospital Luis Alcañiz
Xàtiva, Valencia
About this study
Official title: Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
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 two arms of treatment: placebo and active.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Depigoid Parietaria judaica 1000DPP/ml, Placebo
- Keywords
- allergic, rhinoconjunctivitis, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depigoid Parietaria judaica 1000DPP/mlBiological
Also called A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.
Subcutaneous monthly treatment
PlaceboBiological
Subcutaneous monthly treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml. Receives: Biological: Depigoid Parietaria judaica 1000DPP/ml |
| 2 | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms score
Measured: 2 years
Secondary outcomes (1)
Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angel Ferrer, Dr, Principal investigator, Hospital Vega Baja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916760
- Sponsor's protocol ID
- 2006-005871-17
- Status last verified
- Aug 2012
- First submitted
- 8 Jun 2009
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen
- ClinicalTrials.gov ID
- NCT00916760
- Acronym / sponsor ID
- 2006-005871-17
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- allergic, rhinoconjunctivitis, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jun 2009 (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 assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
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 two arms of treatment: placebo and active.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Depigoid Parietaria judaica 1000DPP/mlA Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml. |
| 2 | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent, signed by the subject
- Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
- Patient of both gender aged from 18 up to 55
- Diagnosed Sensitivity to Parietaria pollen base on:
- Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L
Key exclusion criteria (10 listed)
- Relevant sensitivity to another perenne allergen
- Patient with asthma
- Use of immunotherapy during the last four years
- Treatment with B. Blocking agents
- Patient suffering from some pathology in which adrenaline was contraindicated
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 Parietaria judaica 1000DPP/mlAlso: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.Subcutaneous monthly treatment | Biological | 1 |
| PlaceboSubcutaneous monthly treatment | Biological | 2 |
Primary outcome
Symptoms score
Time frame: 2 years
1 secondary outcome
Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
Related trials for Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
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.
Angel Ferrer, Dr principal investigator
Hospital Vega Baja
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depigoid Parietaria judaica 1000DPP/ml in people with Allergic Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 11 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 6 inclusion and 10 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 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptoms score (time frame: 2 years). 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 11 Nov 2013.