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

Phase 4

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Salbutamol + Tiotropium; Drug: Placebo + Tiotropium

• Registration Number: NCT00783250
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Primary Completion: 2011-08
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salbutamol+Tiotropium	Salbutamol + Tiotropium	Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
placebo + Tiotropium	Placebo + Tiotropium	Placebo using MDI + administration of Tiotropium after 20 minutes

Primary Outcome Measures

Name	Time	Method
Recordings of respiratory mechanics	90 minutes

Secondary Outcome Measures

Name	Time	Method
Dyspnea score	90 minutes

Trial Locations

Locations (1)

Respiratory Unit Fondazione S.Maugeri; 🇮🇹 Pavia, PV, Italy