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Rhinitis, Allergic, PerennialPhase 3NCT01630135

Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

A Phase 3 study testing Fluticasone furoate in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 22 sites in Japan.

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

Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Rhinitis, Allergic, Perennial
What is being tested?
Fluticasone furoate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
22 sitesJapan
Study dates
Jun 2012to Aug 2012
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 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Informed Consent
  • 6 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
  • Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
  • Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
  • ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN
  • Average of 3TNSS is >= 4.0 in the last consecutive 4 days prior to Visit 2.
  • Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2

Who cannot join

  • Has a seasonal pollen as an allergen
  • A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
  • Bacterial or viral infection of upper respiratory tract or eye
  • Concurrent disease/abnormalities: Clinically significant uncontrolled disease
  • Known hypersensitivity to corticosteroids or any excipients in the investigational product
  • Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
Show all 12Show fewer
  • Use of the following medication and/or its combination drug within the specified time:
  • Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1
  • Affiliation with Investigator's Site: Relative or employee
  • History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
  • Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit 2.
  • Bacterial or viral infection of upper respiratory tract or eye during the screening period.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • GSK Investigational Site

    Chiba, 261-0004

  • GSK Investigational Site

    Chiba, 270-0034

  • GSK Investigational Site

    Chiba, 272-0143

  • GSK Investigational Site

    Chiba, 277-0882

  • GSK Investigational Site

    Chiba, 279-0012

  • GSK Investigational Site

    Gifu, 501-3247

  • GSK Investigational Site

    Hokkaido, 001-0923

  • GSK Investigational Site

    Hokkaido, 061-1133

  • GSK Investigational Site

    Hokkaido, 062-0034

  • GSK Investigational Site

    Kanagawa, 222-0011

  • GSK Investigational Site

    Kanagawa, 222-0031

  • GSK Investigational Site

    Kanagawa, 232-0056

  • GSK Investigational Site

    Saitama, 333-0861

  • GSK Investigational Site

    Saitama, 350-1205

  • GSK Investigational Site

    Saitama, 354-0018

  • GSK Investigational Site

    Saitama, 355-0062

  • GSK Investigational Site

    Tokyo, 114-0023

  • GSK Investigational Site

    Tokyo, 125-0052

  • GSK Investigational Site

    Tokyo, 151-0072

  • GSK Investigational Site

    Tokyo, 160-0017

  • GSK Investigational Site

    Tokyo, 170-0005

  • GSK Investigational Site

    Tokyo, 178-0064

Other trials in Japan

About this study

Official title: Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo.

Being tested
Fluticasone furoate, Placebo
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 furoateDrug

    55 mcg/day, intranasal, 2 weeks

  • PlaceboDrug

    Placebo, intranasal, 2 weeks

Study groups in NCT01630135
Study groupRoleWhat they receive
GW685698XExperimentalGW685698X 55mcg/day
Receives: Drug: Fluticasone furoate
PlaceboPlacebo comparatorPlacebo
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 in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period

    The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.

    Measured: Baseline through the entire treatment period (2 weeks)

Secondary outcomes (15)

  1. Mean Change From Baseline in 3TNSS at Week 1 and Week 2

    The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.

    Measured: Baseline; Week 1 and Week 2

  2. Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2

    The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  3. Mean Change From Baseline in 3TNSS at the Indicated Days

    The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.

    Measured: Baseline; Days 1 through 14

  4. Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2

    The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  5. Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2

    The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  6. Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2

    Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  7. Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2

    Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  8. Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2

    Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  9. Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2

    Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  10. Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2

    Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  11. Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2

    Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  12. Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2

    The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

  13. Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW

    Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).

    Measured: Baseline, Week 1, and Week 2/Early Withdrawal (EW)

  14. Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator

    The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.

    Measured: Week 2/EW

  15. Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant

    The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.

    Measured: Week 2/EW

Timeline

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

  1. First posted28 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630135
Sponsor's protocol ID
116364
Status last verified
Nov 2016
First submitted
26 Jun 2012
Last updated
11 Jan 2017
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone furoate in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 22 sites in Japan.

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 12 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. 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 1 May 2013). 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 in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period (time frame: Baseline through the entire treatment period (2 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 NCT01630135.

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 11 Jan 2017.

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