GOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01360788

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-02-28

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.

Detailed Description

The study will be conducted among three subgroups: symptomatic GOLD stage I patients with COPD, asymptomatic patients GOLD stage I COPD and healthy control subjects with normal lung function. Subjects will be paired for age, sex and smoking history. The project will require three visits. In the initial visit, assessment of the pulmonary function with respiratory symptoms quantification will allow to classify subjects in the proper subgroup. The Medical Research Council (MRC) dyspnea scale will serve as the reference outcome to determine whether COPD patients are symptomatic or not. Patients with an MRC dyspnea score < 2 will be considered asymptomatic. A second questionnaire (ATS-DLD-78) will serve to document cough, expectorations, wheezing and smoking history in every subjects. Body composition will be measured by bioimpedance and by waist circumference after a blood sample taken in the morning, in a fasting state. A six-minute walk test (6MWT) will be performed by all subjects. After a one-hour resting period, a maximal incremental shuttle walking test will be realized in the same visit to quantify maximal exercise capacity. Measures of force and endurance of the quadriceps will be taken by magnetic stimulation of the femoral nerve before the maximal walking test. Finally, subjects will receive a portable device to monitor physical activity for a period of 7 days.

In the 2nd and 3rd visits, subjects will realize an endurance walking test at 85 % of their predetermined maximal capacity. Before each endurance test, a bronchodilator or a placebo will be administered following a randomized double-blind design. Measures of force and endurance of the quadriceps will be taken by magnetic stimulation of the femoral nerve before and 10-min after endurance exercise tests. A needle biopsy of the vastus lateralis will be performed at the end of the third visit.

Conditions

Mild Chronic Obstructive Pulmonary Disease; Respiratory Symptoms; Physical Activity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy control subjects

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

No interventions assigned to this group

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.

Combination ipratropium/salbutamol or placebo (nebulization)

Intervention Type: 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.

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.

Combination ipratropium/salbutamol or placebo (nebulization)

Intervention Type: 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.

Interventions

Combination ipratropium/salbutamol or placebo (nebulization)

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.

Intervention Type: DRUG

Other Intervention Names

Combivent or placebo (nebulization)

Eligibility Criteria

Inclusion Criteria

• Smoking history (≥ 10 pack/year)

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Institut Universitaire de cardiologie et de pneumologie de Québec

Principal Investigators

François Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25906326 (View on PubMed)

Other Identifiers

GOLD-20378

Identifier Type: -

Identifier Source: org_study_id