Trial · NCT00723021
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, 24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline,24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 12 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L/Sec | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | Baseline, 24 hours (hrs) post-dose | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | L | MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | ng*h/mL | MEAN |
| OTHER_PRE_SPECIFIED | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | hrs | MEDIAN | |
| OTHER_PRE_SPECIFIED | Plasma Decay Half-Life (t1/2) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. | Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be \>10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level. | ||
| OTHER_PRE_SPECIFIED | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 14 and 24 hours following dosing in each period. | Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be \>10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level. |
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/NCT00723021/outcomes