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Rhinitis, Allergic, PerennialPhase 4NCT00609674

A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis

A Phase 4 study testing Fluticasone furoate nasal spray in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 37 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Rhinitis, Allergic, Perennial
What is being tested?
Fluticasone furoate nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
37 sitesin 7 countries
Study dates
Jan 2008to Jun 2008
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects eligible for enrollment in the study must meet all of the following criteria:
  • Informed consent
  • Subject has provided an appropriately signed and dated informed consent.
  • An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
  • Outpatient
  • Subject is treatable on an outpatient basis.
Show all 38Show fewer
  • Age
  • ≥ 12 years at Visit 2
  • ≥ 18 years at Visit 1 for Russia and Germany
  • Male or eligible female. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed for all females of childbearing potential at Visits 1, 2, 5, and Visit 6/Early Withdrawal to determine if the subject is pregnant.
  • To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
  • Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
  • Oral contraceptive (either combined estrogen/progestin or progestin only),
  • Injectable progestogen,
  • Implants of levonorgestrel,
  • Percutaneous contraceptive patches,
  • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
  • Male partner who is sterile (vasectomy with documentation of azospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject,
  • Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide,
  • Estrogenic vaginal ring
  • Diagnosis of PAR to include:
  • A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.
  • A positive skin test is defined as a wheal ≥3mm larger than the diluent control for prick testing.
  • Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms would include nasal congestion, rhinorrhea, nasal itching and sneezing, eye itching/burning, eye tearing/watering, and eye redness.
  • In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
  • NOTE: Subjects who meet the above criteria for PAR and who also have a history of allergy to a seasonal pollen that will be present in their geographic area during study participation are NOT eligible for randomization.
  • Environment
  • Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain same environment throughout the study.
  • Ability to comply with study procedures
  • Subject understands and is willing, able and likely to comply with study procedures and restrictions.
  • Literate
  • Subject must be able to read, comprehend, and record information in English or native language.
  • Randomization Criteria
  • At Visit 2, the subject must meet the following criteria:
  • Average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the four 24-hours periods prior to randomization must be ≥6. This includes the AM assessment on the morning of the randomization visit.
  • Average of the last 8 reflective nasal symptom assessments for congestion (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomization must be ≥2. This includes the AM assessment on the morning of the randomization visit.
  • Average of the last eight rTOSS assessments (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomization must be ≥ 4. This includes the AM assessment on the morning of the randomization visit.
  • The subject has demonstrated the ability to comply with the use of the daily e-diary, defined as completion of at least 80% of the assessments during the screening period.

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Significant concomitant medical conditions, defined as but not limited to:
  • a historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
  • a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug
  • nasal (e.g., nasal septum) or ocular injury/surgery in the last 3 months
  • asthma, with the exception of mild intermittent asthma [NAEPP, 2007; GINA, 2006], or very mild asthma (Canada) [Lemiére, 2004].
Show all 55Show fewer
  • NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
  • rhinitis medicamentosa
  • bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
  • documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
  • current or history of glaucoma and/or ocular herpes simplex
  • current cataract
  • physical impairment that would affect subject's ability to participate safely and fully in the study
  • clinical evidence of a Candida infection of the nose
  • history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
  • history of adrenal insufficiency
  • Use of corticosteroids, defined as:
  • Intranasal corticosteroid within 4 weeks prior to Visit 1 (e.g., FLONASE™, VERAMYST, Nasonex, Rhinocort).
  • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less, or equivalent) within 8 weeks prior to Visit 1.
  • Use of other allergy medications within the timeframe indicated relative to Visit 1
  • Intranasal or ocular cromolyn within 14 days prior to Visit 1 (e.g., Nasalcrom, Crolom)
  • Short-acting prescription and non-prescription antihistamines, including ocular preparations and antihistamines contained in insomnia and "night time" pain formulations, within 3 days prior to Visit 1 (e.g., Benadryl, Chlortrimeton, Dimetane, Tavist)
  • Long-acting antihistamines within 10 days prior to Visit 1, including loratadine, desloratadine, fexofenadine, cetirizine, levocetirizine, terfenadine (e.g., Allegra, Claritin, Clarinex, Zyrtec)
  • Long-acting antihistamine, astemizole, within 12 weeks prior to Visit 1
  • Intranasal antihistamines (e.g., Astelin) within 2 weeks prior to Visit 1
  • Oral or intranasal decongestants within 3 days prior to Visit 1 (e.g., Sudafed)
  • Long-acting beta-agonists within 3 days prior to Visit 1 (e.g., SEREVENT™, Foradil)
  • Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1 (e.g., Atrovent)
  • Histamine H2-receptor antagonists including cimetidine, ranitidine, famotidine, nizatidine (e.g., ZANTAC™, Tagamet, Pepcid, Axid) within 1 day prior to Visit 1
  • Oral antileukotrienes within 3 days of Visit 1 (e.g., Singulair)
  • Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
  • Subjects are not permitted to use any artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods. No exclusion period prior to screening (Visit 1) is required for these treatments.
  • Use of other medications that may affect allergic rhinitis or its symptoms
  • Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug
  • Use of other intranasally administered medications (e.g., Miacalcin)
  • Use of immunosuppressive medications eight weeks prior to screening and during the study
  • Immunotherapy Immunotherapy patients may be enrolled in the study as long as the immunotherapy was not initiated within 30 days of Visit 1 and if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
  • Use of any medications that significantly alter the pharmacokinetics of fluticasone furoate, including ritonavir and ketoconazole
  • Allergy/Intolerance
  • Known hypersensitivity to corticosteroids, or any excipients in the product
  • Use of contact lenses
  • Use of Nasal Continuous Positive Airway Pressure (C-PAP) device (mask or pillow)
  • Clinical trial/experimental medication experience
  • Participation in a clinical trial within 12 months prior to Visit 1
  • Participation in a previous or current FFNS (GW685698X) clinical study
  • Positive pregnancy test or female who is breastfeeding
  • Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
  • Affiliation with investigational site
  • Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
  • Current tobacco use
  • Subject currently uses, or has used within the past year, smoking products including cigarettes, cigars, and pipe or chewing tobacco.
  • Chickenpox or measles
  • A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last three weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.
  • Findings of a clinically significant, abnormal electrocardiogram (ECG)
  • Findings of a clinically significant laboratory abnormality

Trial locations and contacts

37 sites in 7 countries.

37 sites in 7 countries

United States12 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Ocean City, New Jersey, 07712

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Providence, Rhode Island, 02906

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Wheaton, Maryland, 20902

Other trials in United States

Canada10 sites

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Kanata, Ontario, K2L 3C8

  • GSK Investigational Site

    Mississauga, Ontario, L5A 3V4

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4G2

  • GSK Investigational Site

    Québec, Quebec, G1V 4M6

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7H 0V1

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Winnipeg, Manitoba, R2M 5L9

Other trials in Canada

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1015

  • GSK Investigational Site

    Budapest, 1116

  • GSK Investigational Site

    Budapest, 1148

  • GSK Investigational Site

    Budapest, 1204

Other trials in Hungary

Germany3 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10787

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

Other trials in Germany

Russia3 sites

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Moscow, 123095

  • GSK Investigational Site

    Saint Petersburg, 190013

Other trials in Russia

Slovakia3 sites

  • GSK Investigational Site

    Banská Bystrica, 975 17

  • GSK Investigational Site

    Bratislava, 812 50

  • GSK Investigational Site

    Prešov, 080 01

Other trials in Slovakia

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)

The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.

Being tested
Fluticasone furoate nasal spray, Placebo
Keywords
Perennial allergic rhinitis; fluticasone furoate nasal spray
Medical subject headings
Rhinitis, Allergic, Perennial

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

  • PlaceboDrug

    Placebo

Study groups in NCT00609674
Study groupRoleWhat they receive
fluticasone furoate nasal sprayExperimentalNot described
Receives: Drug: Fluticasone furoate nasal spray
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)

    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

Secondary outcomes (14)

  1. Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)

    The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.

    Measured: Daily; Baseline through End of Study (Week 4)

  2. Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)

    The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  3. Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS

    TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  4. Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS

    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  5. Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS

    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  6. Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing

    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.

    Measured: Daily; Baseline through End of Study (Week 4)

  7. Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.

    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.

    Measured: Daily; Baseline through End of Study (Week 4)

  8. Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)

    The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  9. Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS

    The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.

    Measured: Daily; Baseline through End of Study (Week 4)

  10. Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS

    The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  11. Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.

    The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  12. Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness

    The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.

    Measured: Daily; Baseline through End of Study (Week 4)

  13. Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF

    PNIF: Objective measure of nasal airway flow obstruction.

    Measured: Daily; Baseline through End of Study (Week 4)

  14. Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])

    RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.

    Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

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
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609674
Sponsor's protocol ID
FFU111439
Status last verified
Nov 2016
First submitted
24 Jan 2008
Last updated
16 Dec 2016
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Given JT, Cheema AS, Dreykluft T, Stillerman A, Silvey M, Wu W, Snowise NG, Philpot E. Fluticasone furoate nasal spray is effective and well tolerated for perennial allergic rhinitis in adolescents and adults. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):444-50. doi: 10.2500/ajra.2010.24.3534.

    PubMed 21144223

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone furoate nasal spray in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 37 sites in 7 countries.

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 38 inclusion and 55 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada, Hungary, Germany, Russia and 2 more countries. 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 23 Dec 2009). 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?

Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) (time frame: Daily; Baseline through End of Study (Week 4)). 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 NCT00609674, which also lists 1 linked publication.

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 16 Dec 2016.

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