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

NCT00783250 | Terminated Phase 4 DMC

• 1 other identifier: 350
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Respiratory Mechanics; Bronchodilators; COPD patients with poor reversibility

Outcome Measures

Primary Outcomes (1)

• Recordings of respiratory mechanics

  90 minutes

Secondary Outcomes (1)

• Dyspnea score

  90 minutes

Study Arms (2)

Salbutamol+Tiotropium

EXPERIMENTAL

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

Drug: Salbutamol + Tiotropium

placebo + Tiotropium

PLACEBO COMPARATOR

Placebo using MDI + administration of Tiotropium after 20 minutes

Drug: Placebo + Tiotropium

Interventions

Salbutamol + Tiotropium DRUG

Salbutamol 400 micrograms + Tiotropium 18 micrograms

Also known as: Ventolin, Spiriva

Salbutamol+Tiotropium

Placebo + Tiotropium DRUG

Placebo via MDI + Tiotropium 18 micrograms

Also known as: Spiriva

placebo + Tiotropium

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patient with a Tiffenau ratio \<55% and \>25% predicted
• Poor reversibility to an acute bronchodilator test (i.e. FEV1 changes\<10% from baseline)

You may not qualify if:

• Lack of informed consent
• Cancer
• Concomitant lung and airways diseases

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Respiratory Unit Fondazione S.Maugeri

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief ICU

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

IT (1)