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

This study has been terminated.
(Problems with data collection)
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT00783250
First received: October 30, 2008
Last updated: July 16, 2012
Last verified: July 2012

October 30, 2008
July 16, 2012
September 2008
August 2011   (final data collection date for primary outcome measure)
Recordings of respiratory mechanics [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783250 on ClinicalTrials.gov Archive Site
Dyspnea score [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients
Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Salbutamol + Tiotropium
    Salbutamol 400 micrograms + Tiotropium 18 micrograms
    Other Names:
    • Ventolin
    • Spiriva
  • Drug: Placebo + Tiotropium
    Placebo via MDI + Tiotropium 18 micrograms
    Other Name: Spiriva
  • Experimental: Salbutamol+Tiotropium
    Salbutamol will be given at the dose of 400 micrograms and Tiotropium at the dose of 18 micrograms
    Intervention: Drug: Salbutamol + Tiotropium
  • Placebo Comparator: placebo + Tiotropium
    Placebo using MDI + administration of Tiotropium after 20 minutes
    Intervention: Drug: Placebo + Tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
July 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00783250
350
Yes
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Not Provided
Not Provided
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP