A Phase 3 interventional study of fluticasone furoate nasal spray and placebo in Rhinitis, Allergic, Perennial and Allergic Rhinitis, sponsored by GlaxoSmithKline. Completed at 7 sites in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 365 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Subjects can be enrolled when meeting all criteria as below.
Exclusion Criteria:
Subjects should be excluded when meeting one of criteria as below.
Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
vehicle placebo nasal spray
Drug: placebo
fluticasone furoate nasal spray
Drug: fluticasone furoate nasal spray
fluticasone furoate nasal spray 110ug, once daily
placebo
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.
Time frame: Baseline through entire treatment period (Day 1 through Day 14)
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.
Time frame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
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.
Time frame: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
| Milestone | FFNS 110 mcg | Placebo |
|---|---|---|
| Started | 182 | 183 |
| Completed | 177 | 176 |
| Not completed | 5 | 7 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
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.
| Points on a scale | FFNS 110 mcg | Placebo |
|---|---|---|
| Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS) | -4.226 ± 0.1646 | -2.728 ± 0.1656 |
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.
| Points on a scale | FFNS 110 mcg | Placebo |
|---|---|---|
| Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy | -4.2 ± 0.22 | -2.9 ± 0.22 |
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.
| Points on a scale | FFNS 110 mcg | Placebo |
|---|---|---|
| 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 | -1.2 ± 0.07 | -0.8 ± 0.07 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FFNS 110 mcg | — | 0/181 (0%) | 13/181 (7.2%) |
| Placebo | — | 0/182 (0%) | 9/182 (4.9%) |
| Event | FFNS 110 mcg | Placebo |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 4/181 | 2/182 |
| NasopharyngitisInfections and infestations | 0/181 | 3/182 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/181 | 0/182 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 2/181 | 0/182 |
| RhinalgiaRespiratory, thoracic and mediastinal disorders | 2/181 | 0/182 |
| DizzinessNervous system disorders | 2/181 | 0/182 |
| Oral herpesInfections and infestations | 1/181 | 0/182 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/181 | 1/182 |
| SputumRespiratory, thoracic and mediastinal disorders | 1/181 | 0/182 |
| RashSkin and subcutaneous tissue disorders | 1/181 | 0/182 |
| Age, Continuous(Years) | FFNS 110 mcg | Placebo | Total |
|---|---|---|---|
| Mean | 31.8 ± 10.72 | 33.0 ± 10.95 | 32.4 ± 10.84 |
| Sex: Female, Male(Participants) | FFNS 110 mcg | Placebo | Total |
|---|---|---|---|
| Female | 97 | 99 | 196 |
| Male | 84 | 83 | 167 |
| Race/Ethnicity, Customized(participants) | FFNS 110 mcg | Placebo | Total |
|---|---|---|---|
| Chinese | 181 | 182 | 363 |
| Not Chinese | 0 | 0 | 0 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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