Trial · NCT01918033
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | Baseline and Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Primary | Number of Participants Experiencing an Adverse Event (AE) | Up to Week 4 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized. |
| Primary | Number of Participants Discontinuing Study Drug Due to an AE | Up to Week 2 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. |
| Secondary | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Baseline and Day 3, Week 1 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Secondary | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms. |
| Secondary | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms. |
| Secondary | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. |
| Secondary | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3, Week 1, Week 2 | The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated. |
| Secondary | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities. |
| Secondary | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms. |
| Secondary | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. |
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
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GET https://conductscience.org/api/trials/v1/NCT01918033/registered