Trial · NCT01067105
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Experiencing Adverse Events (AEs) | Weeks 1-26 | |
| Primary | Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | Weeks 1-26 | |
| Primary | Percentage of Subjects Who Discontinue Due to AEs. | Weeks 1-26 | |
| Secondary | Percentage of Subjects Experiencing Local Nasal AEs | Weeks 1-26 | Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. |
| Secondary | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, and 6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, 6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances | Weeks 0-12 | Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) \* 100% and therefore reported as a percentage. |
| Secondary | Number of Devices With Actuation Consistency | Weeks 0-6 and 6-12 | Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration |
| Secondary | Percentage of Devices With Actuation Consistency | Weeks 0-6 and 6-12 | Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration |
| Secondary | Number of Devices With Major Discrepancies | Weeks 0-6 and 6-12 | A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration |
| Secondary | Percentage of Devices With Major Discrepancies | Weeks 0-6 and 6-12 | A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration |
| Secondary | Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey | Weeks 6 and 12 | Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01067105/registered