Trial · NCT02720081
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 | Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before the first dose of study investigational product (Baseline) | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. |
| Primary | Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 | Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6. |
| Secondary | Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | Up to 4 weeks | A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake "all night"; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing. |
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to 8 weeks | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 6 weeks | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Bilirubin at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Neutrophil (%) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Platelet Count at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in White Blood Cell Count at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Hematocrit (%) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02720081/registered