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

NCT ID: NCT00783250

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Respiratory Mechanics Bronchodilators COPD patients with poor reversibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Salbutamol+Tiotropium

Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms

Group Type EXPERIMENTAL

Salbutamol + Tiotropium

Intervention Type DRUG

Salbutamol 400 micrograms + Tiotropium 18 micrograms

placebo + Tiotropium

Placebo using MDI + administration of Tiotropium after 20 minutes

Group Type PLACEBO_COMPARATOR

Placebo + Tiotropium

Intervention Type DRUG

Placebo via MDI + Tiotropium 18 micrograms

Interventions

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Salbutamol + Tiotropium

Salbutamol 400 micrograms + Tiotropium 18 micrograms

Intervention Type DRUG

Placebo + Tiotropium

Placebo via MDI + Tiotropium 18 micrograms

Intervention Type DRUG

Other Intervention Names

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Ventolin Spiriva Spiriva

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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dr. Stefano Nava

Chief ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Respiratory Unit Fondazione S.Maugeri

Pavia, PV, Italy

Site Status

Countries

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Italy

Other Identifiers

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350

Identifier Type: -

Identifier Source: org_study_id