Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients - Full Text View

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 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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Tiotropium bromide Tiotropium Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:

Recordings of respiratory mechanics [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dyspnea score [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783250

Contacts

Contact: Stefano Nava, MD	0382 592806	stefano.nava@fsm.it
Contact: Annalisa Carlucci, MD	0382 592801	annalisa.carlucci@fsm.it

Locations

Italy
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

Sponsors and Collaborators

Fondazione Salvatore Maugeri

More Information

No publications provided

Responsible Party:	Stefano Nava, Fondazione S.Maugeri
ClinicalTrials.gov Identifier:	NCT00783250 History of Changes
Other Study ID Numbers:	350
Study First Received:	October 30, 2008
Last Updated:	August 17, 2011
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Salvatore Maugeri:

COPD
Respiratory Mechanics
Bronchodilators
COPD patients with poor reversibility

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Tiotropium
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012