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Trial · NCT02088216

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryMedian Number of Exacerbations12 months
An exacerbation of bronchiectasis is defined as either a change in one or more of the common symptoms of bronchiectasis (sputum volume or purulence, dyspnea, cough, and fatigue/malaise) or the onset of new symptoms (fever, pleurisy, haemoptysis or need for antibiotic treatment).
SecondaryChange of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.12 monthsThe change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
SecondaryChange of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa12 monthsThe values in the table were calculated as the value at baseline minus the value at 12 months.
SecondaryChange of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines12 months
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores: the minimum value is 0 and the maximum value is 40. 0-10 points: "slight impact"; 11-20 points: "medium impact"; 21-30 points: "serious impact"; 31-40 points: "very serious impact". The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
SecondaryChange in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines12 monthsThe change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
SecondaryChange of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines12 monthsThe change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
SecondaryChange of Forced Vital Capacity (FVC) From Baselines12 monthsThe change was calculated from two time points as the value at the later time point minus the value at the earlier time point.
SecondaryTime to the First Exacerbation12 months
SecondaryTime to Recurrent Exacerbations12 months
SecondaryNature of Sputum (Number of Patients With Yellow Purulent)12 months
SecondaryAdverse Events (AEs) (Elevation of Liver Enzymes)12 months

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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