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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783250
Recruitment Status : Terminated (Problems with data collection)
First Posted : October 31, 2008
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Salbutamol + Tiotropium Drug: Placebo + Tiotropium Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility
Study Start Date : September 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Salbutamol+Tiotropium
Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
Drug: Salbutamol + Tiotropium
Salbutamol 400 micrograms + Tiotropium 18 micrograms
Other Names:
  • Ventolin
  • Spiriva
Placebo Comparator: placebo + Tiotropium
Placebo using MDI + administration of Tiotropium after 20 minutes
Drug: Placebo + Tiotropium
Placebo via MDI + Tiotropium 18 micrograms
Other Name: Spiriva

Primary Outcome Measures :
  1. Recordings of respiratory mechanics [ Time Frame: 90 minutes ]

Secondary Outcome Measures :
  1. Dyspnea score [ Time Frame: 90 minutes ]

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783250

Respiratory Unit Fondazione S.Maugeri
Pavia, PV, Italy, 27100
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Responsible Party: dr. Stefano Nava, Chief ICU, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Identifier: NCT00783250     History of Changes
Other Study ID Numbers: 350
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Respiratory Mechanics
COPD patients with poor reversibility

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents