Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
Exercise intolerance is a major complain of patients with chronic obstructive pulmonary disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor responsible for the appearance of intolerable dyspnea during exercise. Regular treatment with long-acting bronchodilators promotes a more sustained reduction of hyperinflation and consequent symptom relief and increase in the patient's ability to overcome physical demands of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic bronchodilator that significantly improves lung function, reduces symptoms and improves exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration (\>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily administration. Compared to tiotropium, indacaterol provides evidence that is as effective as tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state of health. However, comparative effects of indacaterol versus tiotropium with regard to outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. We hypothesized that indacaterol and TIO are not different in terms of exercise tolerance and its determinants (dynamic hyperinflation and dyspnea).
Interventions
DRUGIndacaterol
150 µg d.o. during the first 3 weeks
DRUGTiotropium
150 µg d.o. during 3 weeks
Sponsors
Novartis
Irmandade Santa Casa de Misericórdia de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women (neither pregnant nor nursing women) ≥40 years of age, with a history of smoking (\>20 years/pack) and COPD diagnosis according to GOLD criteria. * Post-bronchodilator FEV1 \>50% and \<80%, and FEV1/FVC ≤70% of predicted value.
Exclusion criteria
* Hospital admission due to COPD exacerbation or lung infection in the 6 weeks prior to screening, diagnosis of current or previous bronchial asthma, history of allergic rhinitis or other atopic diseases, or peripheral eosinophilia \>400/mm3. * Inability to discontinue the usual bronchodilator therapy prior to initial screening tests, need for continuous oxygen therapy, or arterial oxygen saturation \<85% at rest, or history of adverse reactions to sympathomimetic amines or use of inhaled medication. * Anemia, hypo- or hyperthyroidism, hyperadrenergic conditions, uncontrolled insulin-dependent diabetes mellitus, malignancy, or any disease or condition that limits exercise capacity other than COPD. * History of drug or alcohol abuse, poor adherence to drug treatment, or treatment with any investigational drug in the month before screening. * Patients with ventricular arrhythmia. * Patients with \<80% oxyhemoglobin saturation during exercise testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise tolerance | 3 weeks | Time between beginning of high intensity constant load (75-85% of the peak achieved in a previous cycloergometer incremental test) cardiopulmonary exercise test and point at which patient cannot tolerate the effort any longer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effort-related dyspnea during daily activities | 3 weeks | — |
| Airway diameter and volume, and extension of pulmonary emphysema by multidetector helical chest computed tomography | 3 weeks | — |
| Exercise dyspnea | 3 weeks | Dyspnea evaluated by Borg scale each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise) |
| Dynamic pulmonary hyperinflation | 3 weeks | Inspiratory capacity measured each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise). |
| Oxidative stress before and after exercise tests | 3 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Participants will register adverse events in clinical research diaries or communicate to investigator during 3-week treatment period | Adverse events, including serious adverse events, will be collected and reported in the CRF (Clinical Research File) of the study. Adverse event is any sign, symptom or undesired medical condition that occurs after the beginning of the study even if said event is not considered related to the drug (or therapy) of study. Information on adverse events either reported voluntarily by the patient, identified through questioning by the investigator, or detected by physical examination, laboratory testing or otherwise, will be collected and recorded. |
Countries
Brazil
Outcome results
None listed