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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double-Blind, Parallel Assignment |
| Conditions: |
Allergic Rhinitis Hayfever |
| Intervention: |
Drug: fluticasone furoate, fexofenadine |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Placebo | No text entered. |
| Fluticasone Furoate 110mcg | No text entered. |
| Fexofenadine 180 mg | No text entered. |
| Placebo | Fluticasone Furoate 110mcg | Fexofenadine 180 mg | |
|---|---|---|---|
| STARTED | 229 | 224 | 227 |
| COMPLETED | 219 | 209 | 214 |
| NOT COMPLETED | 10 | 15 | 13 |
| Adverse Event | 1 | 2 | 1 |
| Protocol Violation | 1 | 5 | 2 |
| Withdrawal by Subject | 1 | 1 | 2 |
| Sponsor Terminated Study | 1 | 0 | 1 |
| Non-compliance with eDiary | 4 | 1 | 1 |
| Subject unable to swallow capsule | 1 | 0 | 1 |
| Logpad compliance <80% | 1 | 0 | 0 |
| Randomized in error | 0 | 1 | 1 |
| Non-compliance | 0 | 2 | 2 |
| Outside pollen area more than 48 hours | 0 | 1 | 0 |
| Declining pollen counts | 0 | 1 | 1 |
| Subject in jail | 0 | 1 | 0 |
| Subject took disallowed drug | 0 | 0 | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Placebo | No text entered. |
| Fluticasone Furoate 110mcg | No text entered. |
| Fexofenadine 180 mg | No text entered. |
| Placebo | Fluticasone Furoate 110mcg | Fexofenadine 180 mg | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
229 | 224 | 227 | 680 |
|
Age [units: Years] Mean ± Standard Deviation |
34.8 ± 12.71 | 34.0 ± 13.55 | 34.3 ± 13.66 | 34.4 ± 13.29 |
|
Gender [units: Number of Participants] |
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| Female | 139 | 152 | 135 | 426 |
| Male | 90 | 72 | 92 | 254 |
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Race/Ethnicity, Customized [units: Number of Participants] |
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| White | 181 | 189 | 181 | 551 |
| African American | 40 | 29 | 42 | 111 |
| Other | 8 | 6 | 4 | 18 |
Outcome Measures
| 1. Primary: | Mean Change From Baseline in the Nighttime Symptom Score (NSS) |
| 2. Secondary: | Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) |
| 3. Secondary: | Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) |
| 4. Secondary: | Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) |
| 5. Secondary: | Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) |
| 6. Secondary: | Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) |
| 7. Secondary: | Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) |
| 8. Secondary: | Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) |
| 9. Secondary: | Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) |
| 10. Secondary: | Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) |
| 11. Secondary: | Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) |
| 12. Secondary: | Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFU109047 |
| Study First Received: | July 17, 2007 |
| Results First Received: | November 17, 2008 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00502775 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |