GOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)

NCT01360788 | Completed DMC

• 1 other identifier: GOLD-20378
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Recently integrated in clinical practice, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification states that a mild (stage I) chronic obstructive pulmonary disease (COPD) is present, in a smoker, when the postbronchodilator forced expired volume in 1 second (FEV1) to forced vital capacity (FVC) ratio is \< 0.7. A major change that was introduced by the GOLD classification system was that COPD could be diagnosed despite an FEV1 that is within normal predicted values (above 80% predicted). Because it suggests diagnosing and detecting COPD earlier than done until very recently in medical practice, the GOLD standards bring in a new reality to clinicians. In fact, this novel COPD classification comes with new research challenges because the functional impacts and systemic consequences related to COPD are mostly documented in patients with moderate to severe stages with little information specifically in GOLD stage I COPD. This information is important if the investigators are to convince physicians that GOLD stage I COPD needs to be diagnosed and eventually treated. The investigators aimed to characterize GOLD stage I COPD patients according to activity-related dyspnea. More specifically, our objectives were to compare: i) baseline pulmonary function ii) exercise capacity iii) quadriceps muscle function iv) levels of physical activity in daily life between symptomatic (Sx) GOLD stage I COPD patients, asymptomatic (ASx) GOLD stage I COPD patients and healthy control subjects (CTRL). The investigators reasoned that exercise tolerance and physical activity levels would be decreased in Sx GOLD stage I COPD patients as it would be similar between ASx GOLD stage I COPD patients and CTRL.

Conditions

Mild Chronic Obstructive Pulmonary Disease; Respiratory Symptoms; Physical Activity

Keywords

chronic obstructive pulmonary disease; lung function; symptoms; activity-related dyspnea; quadriceps muscle function; exercise capacity; physical activity in daily life; muscle biopsy; systemic inflammation; GOLD stage I; pulmonary function

Outcome Measures

Primary Outcomes (1)

• Maximal oxygen consumption

  Exercise capacity was directly assessed following an incremental progressive shuttle test. The exercise capacity was defined as the maximal oxygen consumption (VO2 peak, ml/kg/min) by direct measurements of gas exchanges.

  Baseline

Secondary Outcomes (7)

• Quadriceps muscle force

  Baseline

• Levels of physical activity in daily life

  Baseline

• Oxydative stress

  Baseline

• Pulmonary function

  At baseline and before and 60-min after the nebulization of either placebo or bronchodilator

• Time to exhaustion during a constant intensity exercise test

  Before and 90-min after bronchodilation or placebo

Study Arms (3)

Healthy control subjects

Subjects with a significant smoking history (more than 10 pack-years) and a normal lung function.

Asymptomatic GOLD stage I COPD patients

GOLD stage I COPD (post-bronchodilator forced expiratory volume in 1 second \[FEV1\] \> 80% predicted and FEV1/ forced vital capacity \[FVC\] \< 0.7 and a smoking history \> 10 pack-years) were recruited. A Medical Research Council (MRC) dyspnea score ≥ 2 was used to define the presence of symptoms (dyspnea). Concretely, this group did not present any respiratory symptoms, with a MRC dyspnea score of 1/5.

Drug: Combination ipratropium/salbutamol or placebo (nebulization)

Symptomatic GOLD stage I COPD patients

GOLD stage I COPD (post-bronchodilator forced expiratory volume in 1 second \[FEV1\] \> 80% predicted and FEV1/ forced vital capacity \[FVC\] \< 0.7 and a smoking history \> 10 pack-years) were recruited. A Medical Research Council (MRC) dyspnea score ≥ 2 was used to define the presence of symptoms (dyspnea) in this group.

Drug: Combination ipratropium/salbutamol or placebo (nebulization)

Interventions

Combination ipratropium/salbutamol or placebo (nebulization) DRUG

The COPD patients were randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. The bronchodilation produced by the medication was given in order to evaluate if bronchodilation was effective in increasing exercise tolerance during an endurance shuttle walking test in patients with GOLD stage I COPD.

Also known as: Combivent or placebo (nebulization)

Asymptomatic GOLD stage I COPD patients; Symptomatic GOLD stage I COPD patients

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruted after a participation to a research protocol on i) prevalence of COPD in Canada and ii) early detection of lung cancer. Finally, some participants were recruited following medical consultation with a pneumologist.

You may qualify if:

• Smoking history (≥ 10 pack/year)

You may not qualify if:

• Anticoagulation or coagulation defect
• Hypoxemia or exercise-induced desaturation (SpO2 \< 85%)
• Antibiotic or oral corticosteroid therapy (end of treatment \< 1 month prior to study)
• Anti-inflammatory treatment, exacerbation (\< 3 months)
• Myopathy
• Neuromuscular or locomotor diseases
• Recent cancer
• Unstable cardiac condition
• Asthma

Sponsors & Collaborators

• Laval University: lead
• Boehringer Ingelheim: collaborator
• Pfizer: collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.

  PMID: 25906326 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle biopsies Venous blood samples

MeSH Terms

Conditions

Signs and Symptoms, Respiratory; Motor Activity; Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• François Maltais, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 26, 2011
• Study Start: February 1, 2009
• Study Completion: February 1, 2011
• Last Updated: May 26, 2011

Record last verified: 2011-05

Locations

CA (1)