RhinitisPhase 2NCT02340130
Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
A Phase 2 study testing DP/MG/14-1 and DP/MG/14-2 in people with Rhinitis and Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 3 sites in Spain.
Trial summary
This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhinitis, Rhinoconjunctivitis, Asthma
- What is being tested?
- DP/MG/14-1 and DP/MG/14-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesSpain
- Study dates
- Sep 2014to Jun 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided appropriately signed and dated written informed consent.
- Men and women aged 18 years and 70 years of age at Visit 1.
- Has an FEV1 value 80% of predicted normal value at Visit 1.
- Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
- Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
- If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
- If a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.
Who cannot join
- Any contraindication for treatment with allergen specific immunotherapy.
- Subjects with a previous history of anaphylaxis.
- Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
- Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
- Acute or chronic infectious conjunctivitis.
- Has acute or chronic inflammatory or infectious airways disease.
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- Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
- History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
- Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
- Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Lucus-Augusti
Lugo, 27003
Hosp Ntra Sra de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital de Conxo
Santiago de Compostela, A Coruña, 15706
About this study
Official title: A Multicentre, Open Label, Phase IIb Clinical Trial to Evaluate Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites Mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides Pteronyssinus / Lepidoglyphus Destructor and DP/MG/14-2 Dermatophagoides Pteronyssinus /Blomia Tropicalis) in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
Read the detailed description
The objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.
- Conditions
- Rhinitis, Rhinoconjunctivitis, Asthma
- Being tested
- DP/MG/14-1, DP/MG/14-2
- Medical subject headings
- Rhinitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP/MG/14-1Biological
The administration regimen will consist of a rush build-up régimen and a follow up period
DP/MG/14-2Biological
The administration regimen will consist of a rush build-up régimen and a follow up period
| Study group | Role | What they receive |
|---|---|---|
| DP/MG/14-1 | Experimental | DP/MG/14-1: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period Receives: Biological: DP/MG/14-1 |
| DP/MG/14-2 | Experimental | DP/MG/14-2: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period Receives: Biological: DP/MG/14-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions, according to EACCI 2006 classification, along the study
Measured: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Sanchez, Study chair, Laboratorios Leti, S.L.U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340130
- Sponsor's protocol ID
- 1301-PG-PSC-203
- Status last verified
- Aug 2018
- First submitted
- 13 Jan 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Phase IIb Clinical Trial to Evaluate Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites Mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides Pteronyssinus / Lepidoglyphus Destructor and DP/MG/14-2 Dermatophagoides Pteronyssinus /Blomia Tropicalis) in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
- ClinicalTrials.gov ID
- NCT02340130
- Acronym / sponsor ID
- 1301-PG-PSC-203
- Conditions
- Rhinitis, Rhinoconjunctivitis, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Jan 2015 (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.
This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
Detailed description
The objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP/MG/14-1 | Experimental | Biological: DP/MG/14-1DP/MG/14-1: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period |
| DP/MG/14-2 | Experimental | Biological: DP/MG/14-2DP/MG/14-2: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has provided appropriately signed and dated written informed consent.
- Men and women aged 18 years and 70 years of age at Visit 1.
- Has an FEV1 value 80% of predicted normal value at Visit 1.
- Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
- Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
Key exclusion criteria (10 listed)
- Any contraindication for treatment with allergen specific immunotherapy.
- Subjects with a previous history of anaphylaxis.
- Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
- Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
- Acute or chronic infectious conjunctivitis.
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 |
|---|---|---|
| DP/MG/14-1The administration regimen will consist of a rush build-up régimen and a follow up period | Biological | DP/MG/14-1 |
| DP/MG/14-2The administration regimen will consist of a rush build-up régimen and a follow up period | Biological | DP/MG/14-2 |
Primary outcome
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions
Time frame: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions, according to EACCI 2006 classification, along the study
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 8 Aug 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.
Jaime Sanchez study chair
Laboratorios Leti, S.L.U
3 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 DP/MG/14-1 and DP/MG/14-2 in people with Rhinitis and Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 3 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 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions (time frame: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.). 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 Aug 2018.