Rhinitis, Vasomotor, Vasomotor Rhinitis
Conditions
Keywords
nonallergic rhinitis, GW685698X, VMR, vasomotor rhinitis
Brief summary
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).
Interventions
DRUGGW685698X
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be outpatients. * Diagnosis of VMR (vasomotor rhinitis). * Literate in English or native language.
Exclusion criteria
* Significant concomitant medical condition. * Use corticosteroids or other allergy medications during the study. * Used tobacco products within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Baseline and up to Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | Baseline and up to Week 4 | 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. |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Week 4 (Day 29) or Early Withdrawal | 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. |
Countries
Canada, Czechia, Germany, Norway, Puerto Rico, Romania, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| 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. | 174 |
| Total | 347 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Participant took two different treatment | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Fluticasone Furoate 110 µg QD | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 43.8 Years STANDARD_DEVIATION 15.44 | 43.9 Years STANDARD_DEVIATION 15.06 | 44 Years STANDARD_DEVIATION 14.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 167 Participants | 331 Participants | 164 Participants |
| Sex: Female, Male Female | 124 Participants | 232 Participants | 108 Participants |
| Sex: Female, Male Male | 50 Participants | 115 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 174 |
| other Total, other adverse events | 38 / 173 | 42 / 174 |
| serious Total, serious adverse events | 0 / 173 | 1 / 174 |
Outcome results
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.
Time frame: Baseline and up to Week 4
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | -2.11 Score on a scale | Standard Error 0.15 |
| Fluticasone Furoate 110 µg QD | Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | -2.01 Score on a scale | Standard Error 0.15 |
p-value: 0.60495% CI: [-0.26, 0.45]ANCOVA
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.
Time frame: Baseline and up to Week 4
Population: ITT population. Only participants available at the specified timepoint were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | -1.65 Score on a scale | Standard Error 0.14 |
| Fluticasone Furoate 110 µg QD | Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | -1.59 Score on a scale | Standard Error 0.14 |
p-value: 0.72995% CI: [-0.29, 0.41]ANCOVA
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.
Time frame: Week 4 (Day 29) or Early Withdrawal
Population: ITT Population. Only participants available at the specified time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | No Change | 63 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Mildly Worse | 3 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Moderately Worse | 2 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Significantly Worse | 3 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Significantly Improved | 20 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Moderately Improved | 39 Participants |
| Placebo | Number of Participants Based on Overall Evaluation of Response to Therapy | Mildly Improved | 42 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Significantly Worse | 2 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | No Change | 50 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Mildly Improved | 43 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Mildly Worse | 4 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Moderately Improved | 41 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Moderately Worse | 3 Participants |
| Fluticasone Furoate 110 µg QD | Number of Participants Based on Overall Evaluation of Response to Therapy | Significantly Improved | 28 Participants |
p-value: 0.064Regression, Logistic