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

NCT ID: NCT00783250

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-07-31

Brief Summary

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

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Salbutamol+Tiotropium

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

Group Type: EXPERIMENTAL

Salbutamol + Tiotropium

Intervention Type: DRUG

Salbutamol 400 micrograms + Tiotropium 18 micrograms

placebo + Tiotropium

Placebo using MDI + administration of Tiotropium after 20 minutes

Group Type: PLACEBO_COMPARATOR

Placebo + Tiotropium

Intervention Type: DRUG

Placebo via MDI + Tiotropium 18 micrograms

Interventions

Salbutamol + Tiotropium

Salbutamol 400 micrograms + Tiotropium 18 micrograms

Intervention Type: DRUG

Placebo + Tiotropium

Placebo via MDI + Tiotropium 18 micrograms

Intervention Type: DRUG

Other Intervention Names

Ventolin; Spiriva; Spiriva

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

dr. Stefano Nava

Chief ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Respiratory Unit Fondazione S.Maugeri

Pavia, PV, Italy

Countries

Italy

Other Identifiers

350

Identifier Type: -

Identifier Source: org_study_id