A Phase 4 interventional study of Indacaterol maleate and Placebo in COPD, Lung Diseases and Dyspnea, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-10-29.
Sponsored by University of Milan · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.
Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.
Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
Drug: Indacaterol maleate
Will be administered with the same device by a third independent investigator
Drug: Placebo
Dry powered, 300 mcg, only one inhalation with 24 hours duration
Also known as: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Dry powered, same to study drug, only one inhalation
Intra Thoracic Gas Volume (ITGV)
A complete body plethysmografic test will be performed after indacaterol inhalation
Time frame: 60 minutes after drug inhalation
Forced Expired Volume in the first second (FEV1)
Will be performed: spirometry, Arterial blood sample, measurement of blood pressure and cardiac frequency. All these parameters will be tested 60 minutes after inhalation of Indacaterol 300 micrograms (mcg).
Time frame: 60 minutes after drug inhalation
Partial pressure of arterial oxygen (PaO2)
Arterial gas analysis will be performed evaluating all arterial gases
Time frame: 60 minutes after drug inhalation
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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University of Milan