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

Overview

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 Title of Study: “Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2011

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.

Interventions

  • Drug: Salbutamol + Tiotropium
    • Salbutamol 400 micrograms + Tiotropium 18 micrograms
  • Drug: Placebo + Tiotropium
    • Placebo via MDI + Tiotropium 18 micrograms

Arms, Groups and Cohorts

  • Experimental: Salbutamol+Tiotropium
    • Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
  • Placebo Comparator: placebo + Tiotropium
    • Placebo using MDI + administration of Tiotropium after 20 minutes

Clinical Trial Outcome Measures

Primary Measures

  • Recordings of respiratory mechanics
    • Time Frame: 90 minutes

Secondary Measures

  • Dyspnea score
    • Time Frame: 90 minutes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Provider of Information About this Clinical Study
    • Principal Investigator: dr. Stefano Nava, Chief ICU – IRCCS Azienda Ospedaliero-Universitaria di Bologna

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