Allergic RhinitisPhase 4NCT01076439
An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo
A Phase 4 study testing Fluticasone Furoate Nasal Spray, Olopatadine Nasal Spray and Saline Nasal Spray in people with Allergic Rhinitis, run by ORA, Inc..
Trial summary
The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Fluticasone Furoate Nasal Spray, Olopatadine Nasal Spray and Saline Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provide written informed consent and signed HIPAA form;
- be able and willing to follow all instructions and attend the study visits;
- if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control
- have a positive history of seasonal allergic rhinitis to ragweed;
- have a positive skin test reaction to ragweed of within the past 24 months;
- manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC
Who cannot join
- manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
- have had any nasal surgical intervention in the past;
- have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
About this study
Official title: A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC)
The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
- Conditions
- Allergic Rhinitis
- Being tested
- Fluticasone Furoate Nasal Spray, Olopatadine Nasal Spray, Saline Nasal Spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate Nasal SprayDrug
Fluticasone Furoate Nasal Spray: 110mcg QD
Olopatadine Nasal SprayDrug
Olopatadine Nasal Spray: 2660mcg BID
Saline Nasal SprayDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine Nasal Spray (Patanase) | Active comparator | Not described Receives: Drug: Olopatadine Nasal Spray |
| Fluticasone Furoate Nasal Spray (Veramyst) | Active comparator | Not described Receives: Drug: Fluticasone Furoate Nasal Spray |
| Saline Nasal Spray (Placebo) | Placebo comparator | Not described Receives: Drug: Saline Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Signs and Symptoms (TNSS)
TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.
Measured: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Secondary outcomes (3)
Peak Expiratory Flow Rate (PEFR)
Measured: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Peak Nasal Inspiratory Flow (PNIF)
Measured: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Headaches
Measured: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. J. Crampton, MD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076439
- Sponsor's protocol ID
- 10-270-0006
- Status last verified
- Feb 2012
- First submitted
- 24 Feb 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC)
- ClinicalTrials.gov ID
- NCT01076439
- Acronym / sponsor ID
- 10-270-0006
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- First posted
- 26 Feb 2010 (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 the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olopatadine Nasal Spray (Patanase) | Active comparator | Drug: Olopatadine Nasal Spray |
| Fluticasone Furoate Nasal Spray (Veramyst) | Active comparator | Drug: Fluticasone Furoate Nasal Spray |
| Saline Nasal Spray (Placebo) | Placebo comparator | Drug: Saline Nasal Spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- provide written informed consent and signed HIPAA form;
- be able and willing to follow all instructions and attend the study visits;
- if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control
- have a positive history of seasonal allergic rhinitis to ragweed;
- have a positive skin test reaction to ragweed of within the past 24 months;
Key exclusion criteria (7 listed)
- manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
- have had any nasal surgical intervention in the past;
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 |
|---|---|---|
| Fluticasone Furoate Nasal SprayFluticasone Furoate Nasal Spray: 110mcg QD | Drug | Fluticasone Furoate Nasal Spray (Veramyst) |
| Olopatadine Nasal SprayOlopatadine Nasal Spray: 2660mcg BID | Drug | Olopatadine Nasal Spray (Patanase) |
| Saline Nasal SprayPlacebo | Drug | Saline Nasal Spray (Placebo) |
Primary outcome
Nasal Signs and Symptoms (TNSS)
Time frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure
TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.
3 secondary outcomes
Peak Expiratory Flow Rate (PEFR)
Time frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Headaches
Time frame: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
H. J. Crampton, MD principal investigator
ORA, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Furoate Nasal Spray, Olopatadine Nasal Spray and Saline Nasal Spray in people with Allergic Rhinitis, run by ORA, Inc..
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 7 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: withdrawn, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Nasal Signs and Symptoms (TNSS) (time frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure). 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 22 Feb 2012.