Allergic RhinitisPhase 3NCT01503957
Nasya in Allergic Rhinitis
A Phase 3 study testing Nasya and Saline solution in people with Allergic Rhinitis, run by InQpharm Group at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge. 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?
- Nasya and Saline solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 2012
- 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
- History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
- Written informed consent
Who cannot join
- Clinically significant disease that could interfere with the evaluation of study medication
- Participation in other studies within the last 4 weeks / during the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1
Berlin, State of Berlin, 10117
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge
The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.
- Conditions
- Allergic Rhinitis
- Being tested
- Nasya, Saline solution
- Keywords
- Allergic rhinitis, Allergen, Allergy, Dustmite
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NasyaDevice
Thixotropic nasal spray suspension, 2 sprays in each nostril
Saline solutionDevice
Nasal spray, 2 sprays in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Saline solution | Placebo comparator | Nasal spray Receives: Device: Saline solution |
| Nasya | Experimental | Thixotropic nasal spray suspension Receives: Device: Nasya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Total Nasal Symptom Score
Measured: 75 minutes
Secondary outcomes (2)
Difference in Total Nasal Symptom Score
Measured: Up to 240 minutes
Difference in Total Ocular Symptom Score
Measured: Up to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minoo Lenarz, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503957
- Sponsor's protocol ID
- INQ/023411
- Status last verified
- Oct 2012
- First submitted
- 27 Dec 2011
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge
- ClinicalTrials.gov ID
- NCT01503957
- Acronym / sponsor ID
- INQ/023411
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Allergen, Allergy, Dustmite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Jan 2012 (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 purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline solution | Placebo comparator | Device: Saline solutionNasal spray |
| Nasya | Experimental | Device: NasyaThixotropic nasal spray suspension |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
- Written informed consent
Key exclusion criteria (2 listed)
- Clinically significant disease that could interfere with the evaluation of study medication
- Participation in other studies within the last 4 weeks / during 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 |
|---|---|---|
| NasyaThixotropic nasal spray suspension, 2 sprays in each nostril | Device | Nasya |
| Saline solutionNasal spray, 2 sprays in each nostril | Device | Saline solution |
Primary outcome
Difference in Total Nasal Symptom Score
Time frame: 75 minutes
2 secondary outcomes
Difference in Total Nasal Symptom Score
Time frame: Up to 240 minutes
Difference in Total Ocular Symptom Score
Time frame: Up to 240 minutes
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 26 Oct 2012.
Related trials for Allergic Rhinitis
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
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Minoo Lenarz, MD principal investigator
Charite University, Berlin, Germany
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 Nasya and Saline solution in people with Allergic Rhinitis, run by InQpharm Group at 1 site in Germany.
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 2 inclusion and 2 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 26 Oct 2012. 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 Germany. 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?
Difference in Total Nasal Symptom Score (time frame: 75 minutes). 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 26 Oct 2012.