Local Allergic RhinitisPhase 2ECRL1NCT02123316
Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis
A Phase 2 study testing Pangramin Plus D. pteronyssinus in people with Local Allergic Rhinitis, run by Miguel Blanca Gomez at 1 site in Spain.
Trial summary
To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Local Allergic Rhinitis
- What is being tested?
- Pangramin Plus D. pteronyssinus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Apr 2014
- 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
- Prior to study specific examinations the patient has to give his/her written informed consent.
- Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP).
- Age: 18-55.
- Negative skin prick-test to DP
- Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP>0.35 kU/L
- If applicable negative urine pregnancy test and willingness to use effective form of contraception for the duration of involvement in the study.
Who cannot join
- Severe immunopathological or immunodeficiencies diseases.
- Treatment with beta-blockers, even when administered topically
- Severe psychological disorders
- Severe Atopic Dermatitis
- FEV1 <70% predicted after appropriate pharmacological treatment
- History of hypersensitivity or intolerance to excipients and / or trial medication or other medication to be used for protocol
Show all 9Show fewer
- Inability to adequately perform diagnostic tests or treatment
- Awareness of other inhaled allergens (perennial or seasonal) clinically relevant to the subject and that may interfere with the response evaluation
- Treatment with immunotherapy in the 5 years prior to his inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.
To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.
The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.
- Conditions
- Local Allergic Rhinitis
- Being tested
- Pangramin Plus D. pteronyssinus, Placebo
- Keywords
- local allergic rhinitis, subcutaneous immunotherapy, house dust mite allergy, Dermatophagoides pteronyssinus allergy
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pangramin Plus D. pteronyssinusBiological
Subcutaneous immunotherapy with Dermatophagoides pteronyssinus
PlaceboBiological
Placebo for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Pangramin Plus D. pteronyssinus | Active comparator | Pangramin Plus D. pteronyssinus 100% for subcutaneous injection Receives: Biological: Pangramin Plus D. pteronyssinus |
| Placebo | Placebo comparator | Placebo for subcutaneous injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks.
Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe).
The use of rescue medication was recorded in the patient diary according to the following score:
Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
Measured: Baseline, month 1,3,6,12,18, and 24
Secondary outcomes (6)
Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months
Measured: Baseline, month 1,3,6,12,18, and 24
Change from Baseline response to intradermal test at 1,3,6,12 and 24 months
Measured: Baseline, month 1,3,6,12,18, and 24
Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months
Measured: Baseline, month 1,3,6,12,18, and 24
Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months
Measured: Baseline, month 1,3,6,12,18 and 24
Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months
Measured: Baseline, month 1,3,6,12,18 and 24
Adverse event
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 posted25 Apr 2014 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Blanca Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miguel Blanca Gomez, Plaza del Hospital Civil
- Investigators
- Miguel Blanca, MD, PhD, Principal investigator, Allergy Unit, Regional University Hospital of Malaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123316
- Sponsor's protocol ID
- ECRL12008-003680-39
- Other IDs
- 2008-003680-39, 2008
- Acronym
- ECRL1
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rondon C, Campo P, Salas M, Aranda A, Molina A, Gonzalez M, Galindo L, Mayorga C, Torres MJ, Blanca M. Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial. Allergy. 2016 Jul;71(7):1057-61. doi: 10.1111/all.12889. Epub 2016 Apr 13.
PubMed 27008542
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT02123316
- Acronym / sponsor ID
- ECRL1 / ECRL12008-003680-39
- Conditions
- Local Allergic Rhinitis
- Keywords
- local allergic rhinitis, subcutaneous immunotherapy, house dust mite allergy, Dermatophagoides pteronyssinus allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Miguel Blanca GomezUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Apr 2014 (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.
To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.
The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pangramin Plus D. pteronyssinus | Active comparator | Biological: Pangramin Plus D. pteronyssinusPangramin Plus D. pteronyssinus 100% for subcutaneous injection |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo for subcutaneous injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Prior to study specific examinations the patient has to give his/her written informed consent.
- Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP).
- Age: 18-55.
- Negative skin prick-test to DP
- Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP>0.35 kU/L
Key exclusion criteria (9 listed)
- Severe immunopathological or immunodeficiencies diseases.
- Treatment with beta-blockers, even when administered topically
- Severe psychological disorders
- Severe Atopic Dermatitis
- FEV1 <70% predicted after appropriate pharmacological treatment
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 |
|---|---|---|
| Pangramin Plus D. pteronyssinusSubcutaneous immunotherapy with Dermatophagoides pteronyssinus | Biological | Pangramin Plus D. pteronyssinus |
| PlaceboPlacebo for subcutaneous injection | Biological | Placebo |
Primary outcome
Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
Time frame: Baseline, month 1,3,6,12,18, and 24
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
6 secondary outcomes
Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months
Time frame: Baseline, month 1,3,6,12,18, and 24
Change from Baseline response to intradermal test at 1,3,6,12 and 24 months
Time frame: Baseline, month 1,3,6,12,18, and 24
Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months
Time frame: Baseline, month 1,3,6,12,18, and 24
Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months
Time frame: Baseline, month 1,3,6,12,18 and 24
Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months
Time frame: Baseline, month 1,3,6,12,18 and 24
Adverse event
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 31 Mar 2016.
- Derived from this study: PubMed 27008542Rondon C, Campo P, Salas M, Aranda A, Molina A, Gonzalez M, Galindo L, Mayorga C, Torres MJ, Blanca M. Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial. Allergy. 2016 Jul;71(7):1057-61. doi: 10.1111/all.12889. Epub 2016 Apr 13.
Related trials for Local Allergic Rhinitis
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis
Not yet recruiting
Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR
Adenoidectomy, Tonsillectomy
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.
Miguel Blanca, MD, PhD principal investigator
Allergy Unit, Regional University Hospital of Malaga, Spain
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 Pangramin Plus D. pteronyssinus in people with Local Allergic Rhinitis, run by Miguel Blanca Gomez 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 6 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: finished, as of the sponsor's last update on 31 Mar 2016. 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 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?
Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months (time frame: Baseline, month 1,3,6,12,18, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123316, which also lists 1 linked publication.
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 31 Mar 2016.