Trial · NCT00730756
A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis
NCT00730756, Phase 2, Completed, GlaxoSmithKline; results first posted 2009-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis. Trials, record NCT00730756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis
- NCT number
- NCT00730756
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Fluticasone Furoate Nasal Spray, Placebo Nasal Spray
- First posted
- 2008-08-08
- Last updated
- 2017-04-06
- Results first posted
- 2009-11-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean. |
| Secondary | Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment. |
| Secondary | Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale. |
| Secondary | Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment. |
| Secondary | Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale. |
| Secondary | Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment. |
| Secondary | Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale. |
| Secondary | Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment. |
| Secondary | Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) | Baseline through Week 4 (28 days) | ITT Population | points on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) | Placebo | -2.10 | Standard Error 0.25 | points on a scale | |
| Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) | FFNS 110 mcg | -2.17 | Standard Error 0.23 | points on a scale | |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | Placebo | AM pre-dose iTNSS | -1.82 | Standard Error 0.26 | points on a scale |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | FFNS 110 mcg | AM pre-dose iTNSS | -1.90 | Standard Error 0.24 | points on a scale |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | Placebo | AM rTNSS | -2.13 | Standard Error 0.27 | points on a scale |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | FFNS 110 mcg | AM rTNSS | -2.15 | Standard Error 0.24 | points on a scale |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | Placebo | PM rTNSS | -2.09 | Standard Error 0.25 | points on a scale |
| Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) | FFNS 110 mcg | PM rTNSS | -2.19 | Standard Error 0.23 | points on a scale |
| Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) | Placebo | Rhinorrhea | -0.64 | Standard Error 0.09 | points on a scale |
| Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) | FFNS 110 mcg | Rhinorrhea | -0.72 | Standard Error 0.08 | points on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | STARTED | FFNS 110 mcg | 53 | |
| Overall Study | COMPLETED | Placebo | 45 | |
| Overall Study | COMPLETED | FFNS 110 mcg | 48 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | FFNS 110 mcg | 5 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 49 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FFNS 110 mcg | 3 | 53 | |
| other | Migraine | Nervous system disorders | Placebo | 1 | 49 | |
| other | Migraine | Nervous system disorders | FFNS 110 mcg | 2 | 53 | |
| other | Nasal ulcer | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 49 | |
| other | Nasal ulcer | Respiratory, thoracic and mediastinal disorders | FFNS 110 mcg | 2 | 53 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 49 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | FFNS 110 mcg | 2 | 53 | |
| serious | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 49 | |
| serious | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | FFNS 110 mcg | 1 | 53 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | FFNS 110 mcg | ||
| Total, other adverse events | Placebo | 3 | 49 |
| Total, other adverse events | FFNS 110 mcg | 9 | 53 |
| Total, serious adverse events | Placebo | 0 | 49 |
| Total, serious adverse events | FFNS 110 mcg | 1 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21253453 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FFNS 110 mcg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00730756
GET https://conductscience.org/api/trials/v1/NCT00730756/results?page=2