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Trial · NCT01551758

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean Annual Rate of Moderate or Severe COPD ExacerbationsUp to 54 weeksPrimary Efficacy Analysis Population.Exacerbations per participant per yearLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With Serious Adverse Events (SAEs) of Pneumonia During the StudyUp to 58 weeksThe Intent-to-Treat (ITT) Population: Defined as all participants who were randomised and received at least one prescription of study medicationParticipantsNUMBER
SECONDARYMean Number of Serious Adverse Events of Pneumonia During the StudyUp to 58 weeksITT Population.Mean Number of SAELEAST_SQUARES_MEAN
SECONDARYTime to the First Serious Adverse Event of Pneumonia Occuring in a YearUp to 52 weeksITT PopulationParticipantsNUMBER
SECONDARYNumber of COPD-related Secondary Care Contacts Expressed as Least Square MeanUp to 54 weeksITT Population.Contacts per participant per yearLEAST_SQUARES_MEAN
SECONDARYNumber of COPD-related Primary Care Contacts Expressed Using Least Square MeanUp to 54 weeksITT Population.Contacts per participant per yearLEAST_SQUARES_MEAN
SECONDARYNumber of All Secondary Care Contacts Expressed Using Least Square MeanUp to 54 weeksITT Population.Contacts per participant per yearLEAST_SQUARES_MEAN
SECONDARYNumber of All Primary Care Contacts Expressed Using Least Square MeanUp to 54 weeksITT Population.Contacts per participant per yearLEAST_SQUARES_MEAN
SECONDARYTime to an Event of Discontinuation of Initial Therapy Occurring in a YearUp to 364 daysITT PopulationParticipantsNUMBER
SECONDARYTime to the Addition of a Further COPD Controller Medication Occurring in a YearUp to 364 daysITT PopulationParticipantsNUMBER
SECONDARYTime to First Moderate/Severe Exacerbations Occurring in a YearUp to 364 daysITT PopulationParticipantsNUMBER
SECONDARYTime to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a YearUp to 364 daysITT PopulationParticipantsNUMBER
SECONDARYTime to First Severe Exacerbations Occurring in a YearUp to 364 daysITT PopulationParticipantsNUMBER
SECONDARYNumber of Participants With Fatal Serious Adverse Events of PneumoniaUpto 58 weeksITT PopulationParticipantsNUMBER
SECONDARYNumber of Participants With Non-serious Adverse Drug Reactions (ADR)Up to 54 weeksITT PopulationParticipantsNUMBER
SECONDARYNumber of Participants With Serious Adverse EventsUp to 56 weeksITT PopulationParticipantsNUMBER
SECONDARYNumber of Participants With Serious Adverse Drug ReactionsUpto 12 monthsITT PopulationParticipantsNUMBER

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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