Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Randomized, Open-label, Crossover Clinical Trial to Assess the Effects of Indacaterol 150 µg d.o. Compared to Tiotropium Bromide 5 µg d.o. on Dyspnea, Dynamic Pulmonary Hyperinflation and Exercise Tolerance in Patients With Moderate COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693003
• Other study ID #: ISCMPALABAtrial
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2012
• Last updated: January 6, 2014
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
150 µg d.o. during the first 3 weeks
• Tiotropium
150 µg d.o. during 3 weeks

Locations

Country	Name	City	State
Brazil	Pavilhão Pereira Filho	Porto Alegre	Rio Grande do Sul
Brazil	Pavilhão Pereira Filho	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre	Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	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.	Participants will register adverse events in clinical research diaries or communicate to investigator during 3-week treatment period	Yes
Primary	Exercise tolerance	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.	3 weeks	No
Secondary	Effort-related dyspnea during daily activities		3 weeks	No
Secondary	Airway diameter and volume, and extension of pulmonary emphysema by multidetector helical chest computed tomography		3 weeks	No
Secondary	Oxidative stress before and after exercise tests		3 weeks	No
Secondary	Exercise dyspnea	Dyspnea evaluated by Borg scale each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise)	3 weeks	No
Secondary	Dynamic pulmonary hyperinflation	Inspiratory capacity measured each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise).	3 weeks	No