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Trial · NCT00723021

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Forced Expiratory Volume in 1 Second (FEV1)Baseline, 12 hours (hrs) post-doseThe FEV1 is the maximal volume of air that can be forcefully exhaled in one second
PrimaryChange From Baseline in Forced Expiratory Volume in 1 Second (FEV1)Baseline, 24 hours (hrs) post-doseThe FEV1 is the maximal volume of air that can be forcefully exhaled in one second
SecondaryChange From Baseline in Forced Vital Capacity (FVC)Baseline, 12 hours (hrs) post-doseThe FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
SecondaryChange From Baseline in Forced Vital Capacity (FVC)Baseline,24 hours (hrs) post-doseThe FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
SecondaryChange From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)Baseline, 12 hours (hrs) post-doseThe FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
SecondaryChange From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)Baseline, 24 hours (hrs) post-doseThe FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
OtherArea 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.Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
OtherMaximum Observed Plasma Concentration (Cmax)Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
OtherTime to Reach Maximum Observed Plasma Concentration (Tmax)Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
OtherPlasma Decay Half-Life (t1/2)Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
OtherArea Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]14 and 24 hours following dosing in each period.AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

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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