Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
Information source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Salbutamol + Tiotropium (Drug); Placebo + Tiotropium (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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.
Clinical Details
Official title: Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Recordings of respiratory mechanics
Secondary outcome: Dyspnea score
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Respiratory Unit Fondazione S.Maugeri, Pavia, PV 27100, Italy
Additional Information
Starting date: September 2008
Last updated: July 16, 2012
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