NCT00354354

Brief Summary

Hypothesis: The reduction of dynamic hyperinflation and its negative effects on the respiratory system following a bronchodilator could lead to an improvement of cardiac function in terms of increased cardiac output. This may enhance oxygen delivery to the exercising muscles in COPD patients. Bronchodilator administration may also have an indirect effect on V'O2 kinetics via its action on cardiovascular and pulmonary variables. Objectives:

  1. 1.To evaluate the effects of a bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD during constant work-rate cycle exercise, and to evaluate whether bronchodilators will accelerate, indirectly, phase 2 kinetics (usually slower in COPD patients than normal subjects) and shorten t for V'E, V'CO2 , and V'O2 and shorten half-times for HR and O2 pulse, thus showing an improvement of oxygen transport to the peripheral active muscles.
  2. 2.To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation, and its effects on cardiovascular and pulmonary function, on exercise limitation in COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

3.3 years

First QC Date

July 18, 2006

Last Update Submit

April 18, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDCombiventExerciseBronchodilatorKinetics

Outcome Measures

Primary Outcomes (4)

  • effects of bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD during constant work-rate cycle exercise.

    2 hours post-inhalation of study drug

  • evaluate whether bronchodilators will accelerate, indirectly, phase 2 kinetics in COPD

    2 hours post-inhalation of study drug

  • evaluate whether bronchodilators will shorten t for V'E, V'CO2 , and V'O2

    2 hours post-inhalation of study drug

  • evaluate whether bronchodilators will shorten half-times for HR and O2 pulse

    2 hours post-inhalation of study drug

Study Arms (2)

1

EXPERIMENTAL

Combivent

Drug: Combivent

2

PLACEBO COMPARATOR

Saline Solution (0.9% NaCl)

Drug: Combivent

Interventions

CombiventDRUG

Nebulized Combivent (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered once only to subjects.

Also known as: Ipratropium - Salbutamol
12

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • stable COPD
  • FEV1 \< 60 % predicted
  • severe chronic breathlessness (Baseline Dyspnea Index \< 6)

You may not qualify if:

  • SpO2 at rest \< 90% or a a sustained decrease of \> 4% in arterial O2 saturation during the ergometer test, as determined by pulse oximetry
  • a body mass index (BMI) \< 19 or \> 30
  • chronic oral steroid therapy
  • other medical conditions which could cause or contribute to breathlessness, i.e., heart disease or other respiratory diseases
  • other problem which could interfere with carrying out of exercise testing, i.e., neuromuscular diseases, orthopedic diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Investigation Unit (Queen's University)

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

  • Laveneziana P, Palange P, Ora J, Martolini D, O'Donnell DE. Bronchodilator effect on ventilatory, pulmonary gas exchange, and heart rate kinetics during high-intensity exercise in COPD. Eur J Appl Physiol. 2009 Dec;107(6):633-43. doi: 10.1007/s00421-009-1169-4. Epub 2009 Aug 27.

    PMID: 19711095DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesIpratropiumAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Denis E O'Donnell, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations

CA(1)