Allergic RhinitisPhase 3NCT01014325
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
A Phase 3 study testing Allergen extract in people with Allergic Rhinitis, run by Roxall Medizin at 1 site in Spain.
Trial summary
The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Allergen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Sep 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive history of perennial allergic rhinitis
- Positive screening skin prick test (wheal diameter > 3 mm)
- Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- Signed and dated patient´s Informed Consent,
Who cannot join
- Previous immunotherapy with allergen extracts within the last 3 years,
- Simultaneous participation in other clinical trials,
- Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- Auto-immune disorders,
- Severe chronic inflammatory diseases,
- Malignancy,
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- Alcohol abuse,
- Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
- Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Trial locations and contacts
1 site in 1 country.
Roxall Medizin contact
About this study
The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.
- Conditions
- Allergic Rhinitis
- Being tested
- Allergen extract, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen extractBiological
sublingual application
PlaceboBiological
sublingual application
| Study group | Role | What they receive |
|---|---|---|
| Allergen extract | Experimental | Not described Receives: Biological: Allergen extract |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and medication score
Measured: 1 year
Secondary outcomes (4)
Safety of sublingual application
Measured: 1 year
Protocol of adverse events
Measured: 1 year
Quality of Life Questionnaire
Measured: 1 year
Evaluation of patients' related clinical global improvement
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 posted16 Nov 2009 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roxall Medizin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014325
- Sponsor's protocol ID
- SLG-2009-006B
- Status last verified
- Nov 2015
- First submitted
- 11 Nov 2009
- Last updated
- 3 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
- ClinicalTrials.gov ID
- NCT01014325
- Acronym / sponsor ID
- SLG-2009-006B
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Roxall MedizinIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 16 Nov 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 clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergen extract | Experimental | Biological: Allergen extract |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Positive history of perennial allergic rhinitis
- Positive screening skin prick test (wheal diameter > 3 mm)
- Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- Signed and dated patient´s Informed Consent,
Key exclusion criteria (9 listed)
- Previous immunotherapy with allergen extracts within the last 3 years,
- Simultaneous participation in other clinical trials,
- Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- Auto-immune disorders,
- Severe chronic inflammatory diseases,
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 |
|---|---|---|
| Allergen extractsublingual application | Biological | Allergen extract |
| Placebosublingual application | Biological | Placebo |
Primary outcome
Symptom and medication score
Time frame: 1 year
4 secondary outcomes
Safety of sublingual application
Time frame: 1 year
Protocol of adverse events
Time frame: 1 year
Quality of Life Questionnaire
Time frame: 1 year
Evaluation of patients' related clinical global improvement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Roxall Medizin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allergen extract in people with Allergic Rhinitis, run by Roxall Medizin 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 4 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: status not confirmed, as of the sponsor's last update on 3 Nov 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roxall Medizin (+49408972520), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom and medication score (time frame: 1 year). 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 3 Nov 2015.