GOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)

NCT01360788

Last updated date
Study Location
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mild Chronic Obstructive Pulmonary Disease, Respiratory Symptoms, Physical Activity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Smoking history (≥ 10 pack/year)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Mild Chronic Obstructive Pulmonary Disease, Respiratory Symptoms, Physical ActivityGOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)
NCT01360788
  1. Québec, Quebec
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title GOLD Stage I Chronic Obstructive Pulmonary Disease (COPD)
Official Title GOLD Stage I COPD: Is it Really a Disease ? Exercise Tolerance, Muscle Function and Response to Bronchodilation in GOLD Stage I COPD Patients
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Muscle biopsies Venous blood samples
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.
Condition
  • Mild Chronic Obstructive Pulmonary Disease
  • Respiratory Symptoms
  • Physical Activity
Intervention Drug: 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.
Other Name: Combivent or placebo (nebulization)
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Drug: Combination ipratropium/salbutamol or placebo (nebulization)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 24, 2011)
53
Original Actual Enrollment Same as current
Actual Study Completion Date February 2011
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study:All
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01360788
Other Study ID Numbers GOLD-20378
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr François Maltais, Institut Universitaire de cardiologie et de pneumologie de Québec
Study Sponsor Laval University
Collaborators
  • Boehringer Ingelheim
  • Pfizer
Investigators
Principal Investigator:François Maltais, MDInstitut universitaire de cardiologie et de pneumologie de Québec - Université Laval
PRS Account Laval University
Verification Date May 2011