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Trial · NCT02249247

Registered outcomes24

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

ListOutcomeTime frameDescription
PrimaryChanges in exercise endurancePre-dose, up to 12 weeks after start of treatmentevaluated by constant work load test
SecondaryChanges in breathlessness during constant work load testWeek 4 and week 12 weeks after start of treatmentmeasured by Modified Borg scale: Dyspnea score, leg discomfort
SecondaryChanges in forced expiratory volume in one second (FEV1)Pre-dose, up to 12 weeks after start of treatmentassessed by spirometry
SecondaryChanges in forced vital capacity (FVC)Pre-dose, up to 12 weeks after start of treatmentassessed by spirometry
SecondaryChanges in forced expiratory flow at 25%-75% of FVC (FEF25-75%)Pre-dose, up to 12 weeks after start of treatmentassessed by spirometry
SecondaryChanges in inspiratory capacity (IC)Pre-dose, up to 12 weeks after start of treatmentassessed by spirometry
SecondaryChanges in slow vital capacity (SVC)Pre-dose, up to 12 weeks after start of treatmentassessed by spirometry
SecondaryChange in thoracic gas volumePre-dose, up to 12 weeks after start of treatmentassessed by body plethysmography
SecondaryChanges in total lung capacityPre-dose, up to 12 weeks after start of treatmentassessed by body plethysmography
SecondaryChanges in residual volumePre-dose, up to 12 weeks after start of treatmentassessed by body plethysmography
SecondaryChanges in specific airway conductancePre-dose, up to 12 weeks after start of treatmentassessed by body plethysmography
SecondaryChanges in Mahler dyspnoea questionnairePre-dose, up to 12 weeks after start of treatmentBaseline dyspnoea index / transitional dyspnoea index (BDI/TDI)
SecondaryChanges in chronic respiratory disease questionnaire (CRDQ)Pre-dose, up to 12 weeks after start of treatment
SecondaryChanges in carbon monoxide diffusing capacity (DLco)Pre-dose, up to 12 weeks after start of treatment
SecondaryChanges in diffusing capacity of carbon monoxide corrected for alveolar volume (DLco/VA)Pre-dose, up to 12 weeks after start of treatment
SecondaryChanges in peak expiratory flow rate (PEFR) daily patient recordPre-dose, up to 14 weeks after start of treatmentassessed a.m. and p.m. in daily patient record
SecondaryChanges in 24-hours spontaneous sputum wet weightPre-dose, up 12 weeks after start of treatment
SecondaryChanges in oxygen saturation during constant work load testPre-dose, up to 12 weeks after start of treatmentassessed by pulse oximetry
SecondaryChanges in global evaluation assessed by investigator on a 4-point scalePre-dose, up to 14 weeks after start of treatment
SecondaryClinically relevant changes in vital signs (pulse rate, blood pressure)Pre-dose, up to 14 weeks after start of treatment

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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