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The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline. | Baseline and up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| FFR30007 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Males and females >=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.
The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and up to Week 4 |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period. | Week 4 (Day 29) or Early Withdrawal |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | Los Angeles | California | 90025 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Sacramento | California | 95819 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | San Jose | California | 95128 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Englewood | Colorado | 80112 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Sarasota | Florida | 34233 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60632 | United States |
| GSK Investigational Site | South Bend | Indiana | 46617 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71105 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | Wheaton | Maryland | 20902 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Brick | New Jersey | 8724 | United States |
| GSK Investigational Site | Skillman | New Jersey | 08558 | United States |
| GSK Investigational Site | Ithaca | New York | 14850 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Sylvania | Ohio | 43560 | United States |
| GSK Investigational Site | Blue Bell | Pennsylvania | 19422 | United States |
| GSK Investigational Site | Providence | Rhode Island | 2906 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| GSK Investigational Site | Dallas | Texas | 75231-4307 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8M 1K7 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| GSK Investigational Site | Brno | 656 51 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Pilsen | 301 00 | Czechia |
| GSK Investigational Site | Prague | 150 06 | Czechia |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90443 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65187 | Germany |
| GSK Investigational Site | Berlin | 12163 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | 14057 | Germany |
| GSK Investigational Site | Oslo | N-0264 | Norway |
| GSK Investigational Site | Oslo | N-0594 | Norway |
| GSK Investigational Site | Ponce | 00716 | Puerto Rico |
| GSK Investigational Site | Bucharest | 022102 | Romania |
| GSK Investigational Site | Iași | 700115 | Romania |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30007 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Fluticasone Furoate 110 µg QD |
Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. |
| BG001 | Fluticasone Furoate 110 µg QD | Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline. | Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and up to Week 4 |
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| Secondary | Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value. | ITT population. Only participants available at the specified timepoint were analyzed. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and up to Week 4 |
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| Secondary | Number of Participants Based on Overall Evaluation of Response to Therapy | Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period. | ITT Population. Only participants available at the specified time point were analyzed. | Posted | Number | Participants | Week 4 (Day 29) or Early Withdrawal |
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Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34).
ITT Population was used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. | 0 | 173 | 0 | 173 | 38 | 173 |
| EG001 | Fluticasone Furoate 110 µg QD | Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. | 0 | 174 | 1 | 174 | 42 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
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