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Rhinitis, Allergic, PerennialPhase 3NCT01231464

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis

A Phase 3 study testing fluticasone furoate nasal spray in people with Rhinitis, Allergic, Perennial and Allergic Rhinitis, run by GlaxoSmithKline at 7 sites in China.

Completed

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

Official record
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Trial summary

The objective of this study is to compare the efficacy and safety of Fluticasone Furoate Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5 day follow up. Read more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
fluticasone furoate nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
365 participants
Where
7 sitesChina
Study dates
Sep 2009to Jul 2010
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects can be enrolled when meeting all criteria as below.
  • Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years
  • Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)
  • Subject must be symptomatic at screening and willing to maintain same environment throughout the study
  • Ability to comply with study procedures
  • Literate

Who cannot join

  • Subjects should be excluded when meeting one of criteria as below.
  • Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
  • Having complications of bacterial/viral infection of upper respiratory tract
  • Having significant systemic diseases
  • History of hypersensitivity to steroids and ingredients
  • Pregnant women or under lactation
Show all 14Show fewer
  • Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
  • Patients planning to travel outside the region
  • Patients judged to be inappropriate by investigators
  • Patients who participated in another study within 4 months before screening
  • Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
  • allergy medications
  • other medications that may affect allergic rhinitis or its symptoms
  • any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310003

  • GSK Investigational Site

    Nanjing, Jiangsu, 210029

  • GSK Investigational Site

    Shanghai, 200001

  • GSK Investigational Site

    Shanghai, 200031

  • GSK Investigational Site

    Wuhan, 430022

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis

The objective of this study is to compare the efficacy and safety of Fluticasone Furoate Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5 day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs, inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS) during treatment period, and the secondary endpoints include mean change from baseline in nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall inference in activities of daily living. Safety measures include AE (Adverse Event) reports, ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition, reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint, only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.

Read the detailed description

This is a multicenter, 2 week, double blind, randomized, placebo controlled trial. 7 investigational sites will be enlisted to randomize at least 360 subjects (outpatients) during 2009 and 2010. Throughout the entire study period, no antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity will be allowed. The run in period will consist of a minimum of 2 days and a maximum of 14 days. During this period, intermittent allergic rhinitis(IAR) or persistent allergic rhinitis(PER) should be diagnosed confirmatively as the definition from the current ARIA (Allergic Rhinitis and its Impact on Asthma) guideline and the coming effective Chinese allergic rhinitis management guideline. Subjects will assess their nasal symptom scores and compliance in dairy cards to confirm whether to meet randomization criteria. During the treatment period, subjects are randomized (1 and 1 ratio) to FFNS 110ug or matching vehicle placebo nasal spray to self administer intranasal treatment once daily for 2 weeks. Subjects will rate their nasal symptom scores and also document their study drug administration and compliance, any medication conditions experienced, and any concomitant medications taken in their dairy cards. Subjects also assess the severity of overall interference in activities of diary living(ADL) at baseline and the end of study treatment in their questionnaire. At baseline and the end of study treatment, investigators rate nasal findings scores by rhinoscopy, and record them in patient notes. A follow up telephone contact will be made 3 to 5 days after completion of study treatment/early withdrawal to assess for any post treatment adverse effects. The primary endpoint is the change from baseline of reflective total nasal symptom score(rTNSS) during treatment period, and the secondary endpoints include at completion of study treatment, mean change from baseline in nasal finding scores by rhinoscopy, and the severity of overall inference in activities of daily living. The safety measures include ECGs, vital exams, physical exams, and AE reports. In addition, reflective total ocular symptom score(rTOSS) will be measured as an explorative endpoint, only in the specific AR patients with severe ocular symptoms.

Being tested
fluticasone furoate nasal spray, placebo
Keywords
safety, efficacy, placebo, allergic rhinitis, fluticasone furoate
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 furoate nasal sprayDrug

    fluticasone furoate nasal spray 110ug, once daily

  • placeboDrug

    placebo

Study groups in NCT01231464
Study groupRoleWhat they receive
placeboPlacebo comparatorvehicle placebo nasal spray
Receives: Drug: placebo
FFNSExperimentalfluticasone furoate nasal spray
Receives: Drug: fluticasone furoate nasal spray

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 the Daily Reflective Total Nasal Symptom Score (rTNSS)

    The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.

    Measured: Baseline through entire treatment period (Day 1 through Day 14)

Secondary outcomes (2)

  1. Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy

    The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.

    Measured: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)

  2. Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living

    The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.

    Measured: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)

Timeline

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

  1. First posted1 Nov 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2010
  4. Study completionJul 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231464
Sponsor's protocol ID
113342
Status last verified
Jun 2017
First submitted
28 Oct 2010
Last updated
6 Jul 2017

Publications

  • Han D, Liu S, Zhang Y, Wang J, Wang D, Kong W, Wang S, Cheng L, Zhang L; Chinese Allergic Rhinitis Collaborative Research Group. Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis. Allergy Asthma Proc. 2011 Nov-Dec;32(6):472-81. doi: 10.2500/aap.2011.32.3474. Epub 2011 Aug 31.

    PubMed 21888757

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluticasone furoate nasal spray in people with Rhinitis, Allergic, Perennial and Allergic Rhinitis, run by GlaxoSmithKline at 7 sites in China.

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 14 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 4 Feb 2011). 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 the Daily Reflective Total Nasal Symptom Score (rTNSS) (time frame: Baseline through entire treatment period (Day 1 through Day 14)). 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 NCT01231464, 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 6 Jul 2017.

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