Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
Information source: Fondazione Salvatore Maugeri
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Fondazione Salvatore Maugeri Overall contact:
Stefano Nava, MD, Phone: 0382 592806, Email: stefano.nava@fsm.it
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
Stefano Nava, MD, Phone: 0382 592806, Email: stefano.nava@fsm.it
Respiratory Unit Fondazione S.Maugeri, Pavia, PV 27100, Italy; Recruiting
Stefano Nava, MD, Phone: 0382 592806, Email: stefano.nava@fsm.it
Annalisa Carlucci, MD, Phone: 0382 592801, Email: annalisa.carlucci@fsm.it
Stefano Nava, MD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: December 2009
Last updated: April 10, 2009
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