A Phase 4 interventional study of Indacaterol maleate and Tiotropium bromide in Healthy and COPD, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-29.
Sponsored by University of Milan · Phase 4, Interventional, and Treatment
Evaluation of small airways both in healthy and Chronic Obstructive Pulmonary Disease (COPD)subjects still today remains a big problem with implications in diagnostic and clinical management. The first lung alteration in smokers is the bronchiolitis and possibility to understand real damage on this anatomical district should be very interesting. The first point of the study will be the SAW evaluation. The two principal technics to do this are: Single Breath Test (SBT) and oesophageal balloon (EB). With SBT is possible to obtain the four expiration phases and so the shift from phase 3 to phase 4 identifying the point called closing capacity (CC). With EB is possible to obtain the lung static pressure-volume curve and after this to identify the point of closing volume (CV). The real concordance of CC and CV has never been studied both in healthy and COPD subjects.
The SBT is performed by pneumotachograph matched with a gas analyzer. Patient breath normally for some seconds, exhales to residual volume (RV) and after that deeply inhales oxygen (100%) to total lung capacity (TLC), then the patient exhales slowly to RV. This test will be repeated a minimum of three times.
The evaluation of CV will be performed by EB. The oesophageal balloon is introduced by nose and located in distal oesophageal tract. By pressure transducer the correct position will be confirmed. After the investigators will perform the evaluation of lung volume, trans pleural pressure and flow. These parameters will be registered at tidal volume, during forced expiration and finally during hyperventilation.
So, after the identification of presence,absence and eventually concordance of CC and CV should be interesting to evaluate the possible effect on SAW of bronchodilators usually used in clinical practice. More in detail, the investigators will administered in random order and after basal evaluation of CV and CC dry powder of indacaterol 300 micrograms (mcg) or Tiotropium 18 mcg. After one hour of drug administration the investigators will repeat the maneuver for CC and CV evaluations. In this way, will be evaluated only the acute effect of the bronchodilators on lung hyperinflation. Each subjects will perform plethysmographic test too. Bronchodilators will be administered only to the COPD patients.
University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Indacaterol 300 mcg via Breezehaler Inhaler will be administered by a third independent investigator not involved in the performing of any of the tests decribed, following a randomization list
Drug: Indacaterol maleate
Tiotropium 18 mcg, via HandiHaler inhaler will be administered by a third independent investigator not involved in the performing of any of the tests decribed, following a randomization list
Drug: Tiotropium bromide
Dry powder, 300 mcg, only one inhalation with 24 hours duration
Also known as: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Dry powder, 18 mcg, only one inhalation with 24 hours duration
Also known as: Spiriva
Closing Volume (CV)
The evaluation of CV will be performed by EB. The oesophageal balloon is introduced by nose and located in distal oesophageal tract. By pressure transducer the correct position will be confirmed. After the investigators will perform the evaluation of lung volume, trans pleural pressure and flow. These parameters will be registered at tidal volume, during forced expiration and finally during hyperventilation.
Time frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011.
Closing Capacity (CC)
The evaluation of CC will be measuired by Single Breath Test (SBT) and performed by pneumotachograph matched with a gas analyzer. Patient breath normally for some seconds, exhales to residual volume (RV) and after that deeply inhales oxygen (100%) to total lung capacity (TLC), then the patient exhales slowly to RV. This test will be repeated a minimum of three times.
Time frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011
Effect of Tiotropium or Indacaterol on CV and CC registration
Possible effect on small airways by two distinct ultra long acting bronchodilators
Time frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011
Comparison concordance of CV and CC
This data will be important to identify the best, easiest and most reliable test for clinical SAW evaluation
Time frame: Participants will be followed for the duration of medical office stay an expected average of 3 hours. The outcome measure will be assessed for the end of october 2011 and will be presented within december 2011
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Milan