Rhinitis, Allergic, PerennialNCT01199757
A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
An observational study of Rhinitis, Allergic, Perennial, run by GlaxoSmithKline.
Trial summary
Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Fluticasone furoate, mometasone furoate and fluticasone propionate
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2009to 1 Aug 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion criteria for physicians: * Qualified after 1965 * See 3 or more AR patients per week * Personally responsible for treatment decisions for patients with AR * Gave consent to participate to complete all tasks for the study duration 90 Primary Care Physicians and 45 allergists, each prospectively recruit 4 consecutive patients with SAR who provided consent to participate, for a total of 540 patients. Each physician completed a patient record form for 2 patients on fluticasone furate, 1 patient on mometasone furate and 1 patient on fluticasone propionate.
Who may be able to join
None listed.
Who cannot join
- None specified
About this study
Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.
Read the detailed description
- Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being.
- This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP).
- Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Fluticasone furoate, mometasone furoate, fluticasone propionate
- Keywords
- ocular symptoms, nasal symptoms, Allergic Rhinitis, Symptom Free Days, Quality of Life
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoateDrug
Also called AVAMYS™
cohort of patients receiving fluticasone furate
mometasone furoateDrug
Also called NASONEX™
cohort receiving mometasone furoate
fluticasone propionateDrug
Also called FLIXONASE™
cohort of patients on fluticasone propionate
| Study group | Role | What they receive |
|---|---|---|
| FF | Cohort of patients receiving fluticasome furoate Receives: Drug: Fluticasone furoate | |
| MF | cohort of patients on mometasone furoate Receives: Drug: mometasone furoate | |
| FP | cohort of patients receiving fluticasone propionate Receives: Drug: fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
Measured: 4 weeks
Secondary outcomes (8)
Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in number of work day lost by patients receiving FF, MF or FP
Measured: 4 weeks
Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study start10 Jul 2009
- Primary completion1 Aug 2009
- Study completion1 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- Cross-sectional
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adelphi Real World
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199757
- Sponsor's protocol ID
- 114812
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2010
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8. doi: 10.1111/j.1398-9995.2007.01547.x.
PubMed 17927672Gueron B; Demoly P; Piercy J; Small M. A comparison of patients on Avamys vs Nasonex and Flixonase for Quality of Life and Symptoms Free Days in 3 European countries [Poster 380]. Presented at: XXIXth Congress of the European Academy of Allergy and Clinical Immunology, June 2010, London
Small M, Piercy J, Demoly P, Marsden H. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013 Oct 9;3(1):33. doi: 10.1186/2045-7022-3-33.
PubMed 24107462
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
- ClinicalTrials.gov ID
- NCT01199757
- Acronym / sponsor ID
- 114812
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- ocular symptoms, nasal symptoms, Allergic Rhinitis, Symptom Free Days, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Adelphi Real World
- Study start
- 10 Jul 2009 (actual)
- Primary completion
- 1 Aug 2009 (actual)
- Study completion
- 1 Aug 2009 (actual)
- First posted
- 13 Sep 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.
Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.
Detailed description
- Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being.
- This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP).
- Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FF | – | Drug: Fluticasone furoateCohort of patients receiving fluticasome furoate |
| MF | – | Drug: mometasone furoatecohort of patients on mometasone furoate |
| FP | – | Drug: fluticasone propionatecohort of patients receiving fluticasone propionate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion criteria for physicians: * Qualified after 1965 * See 3 or more AR patients per week * Personally responsible for treatment decisions for patients with AR * Gave consent to participate to complete all tasks for the study duration 90 Primary Care Physicians and 45 allergists, each prospectively recruit 4 consecutive patients with SAR who provided consent to participate, for a total of 540 patients. Each physician completed a patient record form for 2 patients on fluticasone furate, 1 patient on mometasone furate and 1 patient on fluticasone propionate.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None specified
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 furoateAlso: AVAMYS™cohort of patients receiving fluticasone furate | Drug | FF |
| mometasone furoateAlso: NASONEX™cohort receiving mometasone furoate | Drug | MF |
| fluticasone propionateAlso: FLIXONASE™cohort of patients on fluticasone propionate | Drug | FP |
Primary outcome
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
Time frame: 4 weeks
8 secondary outcomes
Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in number of work day lost by patients receiving FF, MF or FP
Time frame: 4 weeks
Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP
Time frame: 4 weeks
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 14 Aug 2017.
- Background: PubMed 17927672Higgins V, Kay S, Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy. 2007;62 Suppl 85:6-8. doi: 10.1111/j.1398-9995.2007.01547.x.
- Results publicationGueron B; Demoly P; Piercy J; Small M. A comparison of patients on Avamys vs Nasonex and Flixonase for Quality of Life and Symptoms Free Days in 3 European countries [Poster 380]. Presented at: XXIXth Congress of the European Academy of Allergy and Clinical Immunology, June 2010, London
- Derived from this study: PubMed 24107462Small M, Piercy J, Demoly P, Marsden H. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013 Oct 9;3(1):33. doi: 10.1186/2045-7022-3-33.
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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, Perennial, 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 0 inclusion and 1 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 Aug 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 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?
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199757, which also lists 3 linked publications.
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 Aug 2017.