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Completed

NCT Number: NCT01360788

GOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Mild Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Activity Pulmonary Disease, Chronic Obstructive Respiratory Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Combivent or placebo (nebulization)

Primary outcomes

  1. Maximal oxygen consumption

    Time frame: Baseline

    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.

Secondary outcomes

  1. Quadriceps muscle force

    Time frame: Baseline

    Quadriceps muscle strength was measured with magnetic stimulation of the femoral nerve.

    Mid-thigh cross-sectional area (MTCSA) was obtained following a computed-tomography scan.

    Quadriceps muscle biopsy was performed to measure muscle metabolism.

  2. Levels of physical activity in daily life

    Time frame: Baseline

    A portable armband was worn by the participants on a 7-days basis to monitor physical activities in daily life.

  3. Oxydative stress

    Time frame: Baseline

    Oxydative stress will be quantified in the blood and in the muscle samples obtained during the muscular biopsy.

  4. Pulmonary function

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

    Pulmonary function will be measured by spirometry and plethysmography in the initial visit. In the subsequent visits, pulmonary function will be measured by spirometry before and 60-min after the nebulization of either placebo or bronchodilator. A computed-tomography scan of the lungs was also assessed

  5. Time to exhaustion during a constant intensity exercise test

    Time frame: Before and 90-min after bronchodilation or placebo

    Time to exhaustion was also defined as exercise tolerance and was assessed during a endurance shuttle walking test 90-min following the nebulization of whether Combivent or Placebo in a double-blind crossover design. It was defined as the time in seconds for which a subject could maintain an intensity of 85% of the maximal oxygen consumption during walking or running.

  6. Systemic inflammation

    Time frame: Baseline

    Systemic inflammation will be studied from blood samples obtained in every participants.

  7. Quadriceps muscle endurance

    Time frame: Baseline

    Quadriceps muscle endurance was defined as the time to exhaustion following a constant quadriceps force corresponding to 50 % of the maximal voluntary contraction.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Boehringer Ingelheim
  • Pfizer

Registry information

Official study title

GOLD Stage I COPD: Is it Really a Disease ? Exercise Tolerance, Muscle Function and Response to Bronchodilation in GOLD Stage I COPD Patients

Acronym: GOLD

Important dates

Study start
2009
Study completion
2011
First posted
May 26, 2011
Registry last updated
May 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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