Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
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|ClinicalTrials.gov Identifier: NCT00783250|
Recruitment Status : Terminated (Problems with data collection)
First Posted : October 31, 2008
Last Update Posted : July 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Salbutamol + Tiotropium Drug: Placebo + Tiotropium||Phase 4|
Studies with long-acting b2-agonists in COPD patients who poorly respond to routine airways obstruction reversibility tests with forced expiratory manoeuvres, such as forced expiratory volume in one second (FEV1), are scarce. Such studies, however, seem to show favourable effects on clinical parameters.
This may explain the subjective improvements and changes in quality of life with long-acting b2-agonists in patients with COPD. The lack of effect on forced expiration tests may be due to early airway collapse and subsequent airflow decline causing underestimation of the existing bronchodilatory effects located more peripherally in the respiratory tract, where the major site of resistance is located in obstructive lung disease.
We therefore design a study aimed to assess the short term effects of one short-acting beta2-agonist vs placebo, and the effects of an additional and sequential administration of a different bronchodilator, like tiotropium bromide (anticholinergic agent) on the work of breathing, and its components (i.e., lung resistances and compliance) of COPD patients with poor reversibility assessed using the classical Pulmonary Function Tests.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||July 2012|
Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
Drug: Salbutamol + Tiotropium
Salbutamol 400 micrograms + Tiotropium 18 micrograms
Placebo Comparator: placebo + Tiotropium
Placebo using MDI + administration of Tiotropium after 20 minutes
Drug: Placebo + Tiotropium
Placebo via MDI + Tiotropium 18 micrograms
Other Name: Spiriva
- Recordings of respiratory mechanics [ Time Frame: 90 minutes ]
- Dyspnea score [ Time Frame: 90 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783250
|Respiratory Unit Fondazione S.Maugeri|
|Pavia, PV, Italy, 27100|