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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Salbutamol + Tiotropium
Placebo + Tiotropium
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Respiratory Mechanics, Bronchodilators, COPD patients with poor reversibility

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Unit Fondazione S.Maugeri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salbutamol+Tiotropium

placebo + Tiotropium

Arm Description

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

Placebo using MDI + administration of Tiotropium after 20 minutes

Outcomes

Primary Outcome Measures

Recordings of respiratory mechanics

Secondary Outcome Measures

Dyspnea score

Full Information

First Posted
October 30, 2008
Last Updated
July 16, 2012
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00783250
Brief Title
Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Problems with data collection
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Respiratory Mechanics, Bronchodilators, COPD patients with poor reversibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salbutamol+Tiotropium
Arm Type
Experimental
Arm Description
Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
Arm Title
placebo + Tiotropium
Arm Type
Placebo Comparator
Arm Description
Placebo using MDI + administration of Tiotropium after 20 minutes
Intervention Type
Drug
Intervention Name(s)
Salbutamol + Tiotropium
Other Intervention Name(s)
Ventolin, Spiriva
Intervention Description
Salbutamol 400 micrograms + Tiotropium 18 micrograms
Intervention Type
Drug
Intervention Name(s)
Placebo + Tiotropium
Other Intervention Name(s)
Spiriva
Intervention Description
Placebo via MDI + Tiotropium 18 micrograms
Primary Outcome Measure Information:
Title
Recordings of respiratory mechanics
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Dyspnea score
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Respiratory Unit Fondazione S.Maugeri
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

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

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