Trial · NCT00809757
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4. |
| Secondary | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3. |
| Secondary | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Secondary | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Secondary | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3. |
| Secondary | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4. |
| Secondary | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Secondary | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Secondary | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort |
| Secondary | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | Baseline, Visit 3, pre-dose (approximately 14 days after randomization) | |
| Secondary | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | |
| Secondary | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | |
| Secondary | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3 | Baseline, Visit 3, pre -dose (approximately 14 days after randomization) | |
| Secondary | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Baseline, Visit 4, pre -dose (approximately 28 days after randomization) | |
| Secondary | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Baseline, Visit 3 (the week prior to Visit 3) and Visit 4 | Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers. |
| Secondary | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4) | Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers. |
| Secondary | Investigator Global Assessment - Question 1 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate the child's asthma symptoms? |
| Secondary | Investigator Global Assessment - Question 2 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your ability to manage the subject's asthma? |
| Secondary | Caregiver Global Assessment - Question 1 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your child's asthma symptoms? |
| Secondary | Caregiver Global Assessment - Question 2 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your ability to manage your child's asthma? |
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.
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