Allergic RhinitisPhase 4NCT01439815
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
A Phase 4 study testing Fluticasone Propionate Nasal Spray and Saline Nasal Spray in people with Allergic Rhinitis and Allergic Conjunctivitis, run by ORA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Allergic Conjunctivitis
- What is being tested?
- Fluticasone Propionate Nasal Spray and Saline Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- develop a compromised lung function at Visits 2-6
- have any presence of active sinus or nasal infection at any visit;
- have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of 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)
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- have had any nasal surgical intervention in the past;
- have a known history of glaucoma
- have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- inability or refusal to discontinue contact lens wear during all visits;
- use disallowed medications during the study or appropriate pre-study washout period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Being tested
- Fluticasone Propionate Nasal Spray, Saline Nasal Spray
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate Nasal SprayDrug
Also called Flonase
two sprays in each nostril once daily
Saline Nasal SprayDrug
two sprays in each nostril once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo Nasal Spray | Placebo comparator | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. Receives: Drug: Saline Nasal Spray |
| Fluticasone Propionate | Active comparator | Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. Receives: Drug: Fluticasone Propionate Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction.
The change in the TNSS score between Day 0 and Day 16 was analyzed.
Measured: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Secondary outcomes (4)
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal itching score between Day 0 and Day 16 was analyzed.
Measured: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average sneezing score between Day 0 and Day 16 was analyzed.
Measured: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average rhinorrhea score between Day 0 and Day 16 was analyzed.
Measured: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal congestion score between Day 0 and Day 16 was analyzed.
Measured: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tarek Shazly, MD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439815
- Sponsor's protocol ID
- 11-100-0007
- Status last verified
- Nov 2020
- First submitted
- 19 Sep 2011
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model
- ClinicalTrials.gov ID
- NCT01439815
- Acronym / sponsor ID
- 11-100-0007
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 24 Mar 2021
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 propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Nasal Spray | Placebo comparator | Drug: Saline Nasal SprayTwo sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
| Fluticasone Propionate | Active comparator | Drug: Fluticasone Propionate Nasal SprayTwo sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. |
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 (11 listed)
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- develop a compromised lung function at Visits 2-6
- have any presence of active sinus or nasal infection at any visit;
- have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
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 Propionate Nasal SprayAlso: Flonasetwo sprays in each nostril once daily | Drug | Fluticasone Propionate |
| Saline Nasal Spraytwo sprays in each nostril once daily | Drug | Placebo Nasal Spray |
Primary outcome
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.
4 secondary outcomes
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
Time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tarek Shazly, MD principal investigator
ORA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Propionate Nasal Spray and Saline Nasal Spray in people with Allergic Rhinitis and Allergic Conjunctivitis, run by ORA, Inc. at 1 site in United States.
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 11 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 14 Apr 2021. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16) (time frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16). 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 14 Apr 2021.