Rhinitis, Allergic, SeasonalNCT01337323
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
An observational study of Rhinitis, Allergic, Seasonal and Seasonal Allergic Rhinitis, run by GlaxoSmithKline.
Trial summary
This study is a prospective observational cohort study with 3-month follow-up among a cohort of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal spray (FFNS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis
- What is being tested?
- Fluticasone furoate nasal spray
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 2011
- Phase
- Observational
- 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
Study population: Adult patients filling a new fluticasone furorate nasal spray (FFNS) prescription will be recruited across 50 branches of a retail pharmacy chain with co-located convenient care clinic located throughout the United States. Approximately 350 patients who have active seasonal rhinitis and have used an intra-nasal steroid (INS) other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be enrolled in the study.
Who may be able to join
- Active seasonal allergic rhinitis
- Initiating first-time treatment with fluticasone furoate nasal spray (FFNS)
- Received treatment with at least one intra-nasal steroid (INS) other than FFNS during the last allergy season
- Received treatment with one or more antihistamines, leukotriene receptor atagonists (LTRA), topical ocular medications, or any over the counter (OTC) medication for allergic rhinitis symptoms during the last allergy season
- At least 18 years of age at the time of study enrollment
- Able to read, comprehend, and record information in English
- Have provided an appropriately signed and dated informed consent
Who cannot join
- Received prior treatment with FFNS
- Pregnant
- Employee or family members of an employee of the study sponsor, retail pharmacy chain, or convenient care clinic implementing the study
About this study
This study is a prospective observational cohort study with 3-month follow-up among a cohort of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost of concomitant allergic rhinitis medications in INS-experienced patients starting treatment with FFNS who have a history of prior concomitant medication use. The secondary aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis Control Assessment Test (RCAT).
Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be eligible for the study. A baseline questionnaire will be administered to collect information on patient demographics, a brief medical history of the patient's rhinitis, prior use of INS and other prescription and over-the-counter medications taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number of office visits due to allergic rhinitis, and level of control of symptoms of allergic rhinitis.
Read more
At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to collect information on medications taken for allergic rhinitis, office visits due to rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment to verify and supplement patient reported data as needed.
The primary outcomes will be rate of use of non-INS concomitant medications (frequency and duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and from baseline to follow-up) and change in the level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.
- Being tested
- Fluticasone furoate nasal spray
- Keywords
- allergic rhinitis, allergies, concomitant medications, allergy symptoms
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate nasal sprayDrug
Also called Flonase® is a registered trademark of GlaxoSmithKline
fluticasone furorate intranasal steroid spray
| Study group | Role | What they receive |
|---|---|---|
| New prescription for fluticasone furoate nasal spray | patients receiving their first prescription for fluticasone furoate nasal spray and who have active seasonal allergic rhinitis with a history of using another intranasal steriod (INS) and other concomitant allergic rhinitis medications to treat their seasonal allergy symptoms. Receives: Drug: Fluticasone furoate nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-intranasal steroid concomitant medication use
change in rate of non-intranasal steroid concomitant medication use (frequency and duration)
Measured: 3 months
Secondary outcomes (2)
Concomitant Medication Cost
Change in total allergic rhinitis pharmacy expenditures
Measured: 3 months
RCAT Score
Level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Insufficient number of patient records met inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337323
- Sponsor's protocol ID
- 112602
- Status last verified
- May 2017
- First submitted
- 15 Apr 2011
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
- ClinicalTrials.gov ID
- NCT01337323
- Acronym / sponsor ID
- 112602
- Keywords
- allergic rhinitis, allergies, concomitant medications, allergy symptoms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient number of patient records met inclusion criteria
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Apr 2011 (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 study is a prospective observational cohort study with 3-month follow-up among a cohort of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost of concomitant allergic rhinitis medications in INS-experienced patients starting treatment with FFNS who have a history of prior concomitant medication use. The secondary aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis Control Assessment Test (RCAT).
Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be eligible for the study. A baseline questionnaire will be administered to collect information on patient demographics, a brief medical history of the patient's rhinitis, prior use of INS and other prescription and over-the-counter medications taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number of office visits due to allergic rhinitis, and level of control of symptoms of allergic rhinitis.
At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to collect information on medications taken for allergic rhinitis, office visits due to rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment to verify and supplement patient reported data as needed.
The primary outcomes will be rate of use of non-INS concomitant medications (frequency and duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and from baseline to follow-up) and change in the level of control of allergic rhinitis, as measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New prescription for fluticasone furoate nasal spray | – | Drug: Fluticasone furoate nasal spraypatients receiving their first prescription for fluticasone furoate nasal spray and who have active seasonal allergic rhinitis with a history of using another intranasal steriod (INS) and other concomitant allergic rhinitis medications to treat their seasonal allergy symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients filling a new fluticasone furorate nasal spray (FFNS) prescription will be recruited across 50 branches of a retail pharmacy chain with co-located convenient care clinic located throughout the United States. Approximately 350 patients who have active seasonal rhinitis and have used an intra-nasal steroid (INS) other than FFNS and another prescription or over-the-counter allergy medication in the previous allergy season will be enrolled in the study.
Key inclusion criteria (7 listed)
- Active seasonal allergic rhinitis
- Initiating first-time treatment with fluticasone furoate nasal spray (FFNS)
- Received treatment with at least one intra-nasal steroid (INS) other than FFNS during the last allergy season
- Received treatment with one or more antihistamines, leukotriene receptor atagonists (LTRA), topical ocular medications, or any over the counter (OTC) medication for allergic rhinitis symptoms during the last allergy season
- At least 18 years of age at the time of study enrollment
Key exclusion criteria (3 listed)
- Received prior treatment with FFNS
- Pregnant
- Employee or family members of an employee of the study sponsor, retail pharmacy chain, or convenient care clinic implementing 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 |
|---|---|---|
| Fluticasone furoate nasal sprayAlso: Flonase® is a registered trademark of GlaxoSmithKlinefluticasone furorate intranasal steroid spray | Drug | New prescription for fluticasone furoate nasal spray |
Primary outcome
Non-intranasal steroid concomitant medication use
Time frame: 3 months
change in rate of non-intranasal steroid concomitant medication use (frequency and duration)
2 secondary outcomes
Concomitant Medication Cost
Time frame: 3 months
RCAT Score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Insufficient number of patient records met inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, Seasonal and Seasonal Allergic Rhinitis, run by GlaxoSmithKline.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient number of patient records met inclusion criteria). Results are not available in the source record.
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?
Non-intranasal steroid concomitant medication use (time frame: 3 months). 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 30 May 2017.