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| Sponsor: | Fondazione Salvatore Maugeri |
|---|---|
| Information provided by: | Fondazione Salvatore Maugeri |
| ClinicalTrials.gov Identifier: | NCT00783250 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Salbutamol + Tiotropium Drug: Placebo + Tiotropium |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Bronchodilators on Respiratory Mechanics in COPD Patients With Poor Reversibility |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Salbutamol+Tiotropium: Experimental
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
|
|
placebo + Tiotropium: Placebo Comparator
Placebo using MDI + administration of Tiotropium after 20 minutes
|
Drug: Placebo + Tiotropium
Placebo via MDI + Tiotropium 18 micrograms
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefano Nava, MD | 0382 592806 | stefano.nava@fsm.it |
| Contact: Annalisa Carlucci, MD | 0382 592801 | annalisa.carlucci@fsm.it |
| Italy, PV | |
| Respiratory Unit Fondazione S.Maugeri | Recruiting |
| Pavia, PV, Italy, 27100 | |
| Contact: Stefano Nava, MD 0382 592806 stefano.nava@fsm.it | |
| Contact: Annalisa Carlucci, MD 0382 592801 annalisa.carlucci@fsm.it | |
| Principal Investigator: Stefano Nava, MD | |
More Information
| Responsible Party: | Fondazione S.Maugeri ( Stefano Nava ) |
| Study ID Numbers: | 350 |
| Study First Received: | October 30, 2008 |
| Last Updated: | December 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00783250 History of Changes |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
|
COPD Respiratory Mechanics Bronchodilators COPD patients with poor reversibility |
|
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Albuterol Reproductive Control Agents Cholinergic Agents Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases |
Tocolytic Agents Therapeutic Uses Tiotropium Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
