Allergic RhinitisPhase 2NCT00758446
Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis
A Phase 2 study testing BLX-028914 in people with Allergic Rhinitis, run by Dart NeuroScience, LLC at 1 site in Sweden.
Trial summary
This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- BLX-028914
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Jan 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 50 years of age (inclusive), male or female
- Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
- History of pollen-induced seasonal allergic rhinitis but otherwise healthy
- Positive skin prick test for timothy and/or birch allergen
- Sufficient reaction to nasally administered allergen at screening
- Signed informed consent obtained
Who cannot join
- Expected symptoms of seasonal allergic rhinitis during the study period
- Asthma
- Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
- Anti-allergy immunotherapy in the previous two years
- Extensive use of nasal sprays
- Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
Show all 13Show fewer
- Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
- Smoking within 3 months of first treatment period
- Clinically significant laboratory findings
- Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
- Known hypersensitivity to any constituent of the study medication or placebo
- Participation in any other investigational study in the last three months
- Subject anticipated not being able to adhere to study plan according to investigator judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis
This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.
The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.
- Conditions
- Allergic Rhinitis
- Being tested
- BLX-028914, 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.
BLX-028914Drug
50 mg capsules, p.o, daily, 14 days
BLX-028914Drug
15 mg capsules, p.o, daily, 14 days
placeboDrug
capsules, p.o, daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | BLX-028914 50 mg Receives: Drug: BLX-028914 |
| B | Experimental | BLX-028914 15 mg Receives: Drug: BLX-028914 |
| C | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post allergen challenge; Total Nasal Symptom Score(TNSS)
Measured: 10 minutes after allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionJan 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dart NeuroScience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orexo AB
- Responsible party
- Sponsor
- Investigators
- Lennart Greiff, MD, PhD, Principal investigator, Department of otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758446
- Sponsor's protocol ID
- OX914-001
- Status last verified
- Mar 2013
- First submitted
- 22 Sep 2008
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00758446
- Acronym / sponsor ID
- OX914-001
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dart NeuroScience, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Orexo AB
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Sep 2008 (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 a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.
The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BLX-028914BLX-028914 50 mg |
| B | Experimental | Drug: BLX-028914BLX-028914 15 mg |
| C | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 50 years of age (inclusive), male or female
- Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
- History of pollen-induced seasonal allergic rhinitis but otherwise healthy
- Positive skin prick test for timothy and/or birch allergen
- Sufficient reaction to nasally administered allergen at screening
Key exclusion criteria (13 listed)
- Expected symptoms of seasonal allergic rhinitis during the study period
- Asthma
- Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
- Anti-allergy immunotherapy in the previous two years
- Extensive use of nasal sprays
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 |
|---|---|---|
| BLX-02891450 mg capsules, p.o, daily, 14 days | Drug | A |
| BLX-02891415 mg capsules, p.o, daily, 14 days | Drug | B |
| placebocapsules, p.o, daily, 14 days | Drug | C |
Primary outcome
Post allergen challenge; Total Nasal Symptom Score(TNSS)
Time frame: 10 minutes after allergen challenge
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 13 Mar 2013.
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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.
Lennart Greiff, MD, PhD principal investigator
Department of otorhinolaryngology
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 BLX-028914 in people with Allergic Rhinitis, run by Dart NeuroScience, LLC at 1 site in Sweden.
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 13 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 13 Mar 2013. 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 Sweden. 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?
Post allergen challenge; Total Nasal Symptom Score(TNSS) (time frame: 10 minutes after allergen challenge). 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 13 Mar 2013.