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Trial · NCT06999343

Registered outcomes21

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

ListOutcomeTime frameDescription
PrimaryForced expiratory volume in the first second (FEV1)At inclusion and at 3-years follow-upThe amount of air expelled during the first second of a maximal expiration, performed after a maximal inspiration.
PrimaryCarbon monoxide diffusion test (DLCO)At inclusion and at 3-years follow-upPulmonary function test, in which the diffusion of gases through the pulmonary alveoli into the blood is studied.
SecondaryAgeBaselineYears
SecondarySex at birthBaselineMale/Female
SecondaryHeightBaselineCentimetres
SecondaryWeightBaseline and at 1 year, 2 years and 3 yearsKg
SecondarySmokingBaselineCigarette packs/year
SecondaryThe percentage of lung volume with emphysema measured on a chest CT scan.At inclusion and at 3-years follow-up
Secondary6-minute walk distance (6MWT)Baseline and at 1 year, 2 years and 3 yearsMetres in 6 minutes
SecondaryGrip strength with dynamometerBaseline and at 1 year, 2 years and 3 yearsKg
SecondaryBODE IndexBaseline and month 6, 12, 18, 24, 30 and 36
The BODE index will result in a score of zero to ten dependent upon FEV1, body-mass index, the distance walked in six minutes, and the modified MRC dyspnea scale where 0 is the best state of health and 10 is the worst.
SecondaryDyspnoeaBaseline and at 1 year, 2 years and 3 years1, 2, 3, 4 or 5 grades where dyspnoea grade 1 is the best state of health and grade 5 is the worst state of health
SecondaryMajor cardiovascular eventsMonth 6, 12, 18, 24, 30 and 36Select from a list (Myocardial infarction/new angina/stroke) if any of these events happen.
SecondaryCancer eventsMonth 6, 12, 18, 24, 30 and 36Solid cancers Yes/No
SecondaryRenal dysfunction (microalbuminuria)Month 6, 12, 18, 24, 30 and 36mg/g
SecondaryConcomitant treatmentMonth 6, 12, 18, 24, 30 and 36EPOC concomitant treatment
SecondaryExacerbationsMonth 6, 12, 18, 24, 30 and 36YES/NO
SecondaryEmergency room visitsMonth 6, 12, 18, 24, 30 and 36YES/NO
SecondaryHospitalisationsMonth 6, 12, 18, 24, 30 and 36YES/NO
SecondaryIntubationMonth 6, 12, 18, 24, 30 and 36YES/NO

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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