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Trial · NCT01092403

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryLate asthmatic response (LAR)Day 8 of each treatment periodLAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge
PrimaryEarly asthmatic response (EAR)Day 8 of every treatment periodEAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge
PrimaryAirway hyperresponsivenessDays -1, 7 and 9 of each treatment periodDifference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge
PrimarySafety and tolerability
Physical examination: Day 9, vital signs: Days -1, 1, 7, 8 and 9; twelve-lead ECG: Days 1, 7, 8 and 9 , AEs throughout the study, safety laboratory assessments Day 1 and 9 and Chest X-Ray: Day 9 of the final treatment period
SecondaryLAR's FEV1 AUCDay 8 of every treatment periodFrom 3 to 7 hours post-allergen challenge
SecondaryFEV1Day 924 hours post-allergen challenge
SecondaryEAR's FEV1 AUCDay 8From 0 to 3 hours post-allergen challenge
SecondaryChange in FEV1Days 1, 7, 8 and 9Before inhalation of ASM-024 and as soon as possible following inhalation of ASM-024
SecondaryInduced sputum eosinophil count and eosinophil and neutrophil percentagesDays -1, 7 and 9 of every Treatment Period
SecondaryBlood eosinophil countDays -1 and 9 of every Treatment Period
SecondaryTotal and differential WBC countDays -1 and 9 of every Treatment Period

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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