Back to resultsIndacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Indacaterol
Tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
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
Sites / Locations
- Pavilhão Pereira Filho
- Pavilhão Pereira Filho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Indacaterol first
Tiotropium first
Arm Description
Indacaterol 150 µg d.o. during the first 3-week period followed by other 3-week period of tiotropium bromide 5 µg d.o. separated by a "wash-out" phase of at least 5 to 14 days between each treatment period
Tiotropium bromide 5 µg d.o. during the first 3-week period followed by other 3-week period of Indacaterol 150 µg d.o. separated by a "wash-out" phase of at least 5 to 14 days between each treatment period
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effort-related dyspnea during daily activities
Airway diameter and volume, and extension of pulmonary emphysema by multidetector helical chest computed tomography
Oxidative stress before and after exercise tests
Exercise dyspnea
Dyspnea evaluated by Borg scale each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise)
Dynamic pulmonary hyperinflation
Inspiratory capacity measured each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise).
Full Information
NCT ID
NCT01693003
First Posted
September 19, 2012
Last Updated
January 6, 2014
Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01693003
Brief Title
Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indacaterol first
Arm Type
Experimental
Arm Description
Indacaterol 150 µg d.o. during the first 3-week period followed by other 3-week period of tiotropium bromide 5 µg d.o. separated by a "wash-out" phase of at least 5 to 14 days between each treatment period
Arm Title
Tiotropium first
Arm Type
Experimental
Arm Description
Tiotropium bromide 5 µg d.o. during the first 3-week period followed by other 3-week period of Indacaterol 150 µg d.o. separated by a "wash-out" phase of at least 5 to 14 days between each treatment period
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Other Intervention Name(s)
Onbrez Breezhaler®
Intervention Description
150 µg d.o. during the first 3 weeks
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Other Intervention Name(s)
Spiriva Respimat®
Intervention Description
150 µg d.o. during 3 weeks
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Effort-related dyspnea during daily activities
Time Frame
3 weeks
Title
Airway diameter and volume, and extension of pulmonary emphysema by multidetector helical chest computed tomography
Time Frame
3 weeks
Title
Oxidative stress before and after exercise tests
Time Frame
3 weeks
Title
Exercise dyspnea
Description
Dyspnea evaluated by Borg scale each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise)
Time Frame
3 weeks
Title
Dynamic pulmonary hyperinflation
Description
Inspiratory capacity measured each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise).
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
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.
Time Frame
Participants will register adverse events in clinical research diaries or communicate to investigator during 3-week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Z Teixeira, MD
Organizational Affiliation
Santa Casa de Misericórdia de Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Pavilhão Pereira Filho
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90002-090
Country
Brazil
Facility Name
Pavilhão Pereira Filho
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27812637
Citation
Berton DC, Santos AH, Bohn I Jr, Lima RQ, Breda V, Teixeira PJ. Effects of indacaterol versus tiotropium on exercise tolerance in patients with moderate COPD: a pilot randomized crossover study. J Bras Pneumol. 2016 Sep-Oct;42(5):367-373. doi: 10.1590/S1806-37562015000000334.
Results Reference
derived
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Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD
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