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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Terminated; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Salbutamol + Tiotropium; Drug: Placebo + Tiotropium

Study type: Interventional

Funder types: Other

Identifiers

NCT00783250

350

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Salbutamol+Tiotropium

Experimental group

Description:

Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms

Treatment:

Drug: Salbutamol + Tiotropium

placebo + Tiotropium

Placebo Comparator group

Description:

Placebo using MDI + administration of Tiotropium after 20 minutes

Treatment:

Drug: Placebo + Tiotropium