Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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The aim of this study is to assess the effects on respiratory mechanics of one classical short-term bronchodilator (i.e., salbutamol) versus placebo, and to verify the hypothesis that the addition of another bronchodilator (i.e., anticholinergic) may induce a further improvement on the work of breathing of stable COPD patients.

Detailed Description
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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.

Official Title
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Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Salbutamol + Tiotropium
* Drug: Placebo + Tiotropium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patient with a Tiffenau ratio <55% and >25% predicted Poor reversibility to an acute bronchodilator test (i.e. FEV1 changes<10% from baseline) Exclusion Criteria: Lack of informed consent Cancer Concomitant lung and airways diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salbutamol+Tiotropium<br>Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms | Drug: Salbutamol + Tiotropium<br>* Salbutamol 400 micrograms + Tiotropium 18 micrograms<br>* Other names: Spiriva;|
| Placebo Comparator: placebo + Tiotropium<br>Placebo using MDI + administration of Tiotropium after 20 minutes | Drug: Placebo + Tiotropium<br>* Placebo via MDI + Tiotropium 18 micrograms<br>* Other names: Spiriva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recordings of respiratory mechanics |  | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea score |  | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Respiratory Mechanics, Bronchodilators, COPD patients with poor reversibility