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

Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00783250
Enrollment
20
Registered
2008-10-31
Start date
2008-09-30
Completion date
2012-07-31
Last updated
2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Respiratory Mechanics, Bronchodilators, COPD patients with poor reversibility

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.

Interventions

DRUGSalbutamol + Tiotropium

Salbutamol 400 micrograms + Tiotropium 18 micrograms

DRUGPlacebo + Tiotropium

Placebo via MDI + Tiotropium 18 micrograms

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recordings of respiratory mechanics90 minutes

Secondary

MeasureTime frame
Dyspnea score90 minutes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026