Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

NCT ID: NCT01693003

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-31

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).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Indacaterol first

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

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

150 µg d.o. during the first 3 weeks

Tiotropium

Intervention Type: DRUG

150 µg d.o. during 3 weeks

Tiotropium first

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

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

150 µg d.o. during the first 3 weeks

Tiotropium

Intervention Type: DRUG

150 µg d.o. during 3 weeks

Interventions

Indacaterol

150 µg d.o. during the first 3 weeks

Intervention Type: DRUG

Tiotropium

150 µg d.o. during 3 weeks

Intervention Type: DRUG

Other Intervention Names

Onbrez Breezhaler®; Spiriva Respimat®

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Paulo J Z Teixeira

Clinical professor and chair of the study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Z Teixeira, MD

Role: STUDY_CHAIR

Santa Casa de Porto Alegre

Locations

Pavilhão Pereira Filho

Porto Alegre, Rio Grande do Sul, Brazil

Pavilhão Pereira Filho

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 27812637 (View on PubMed)

Other Identifiers

ISCMPALABAtrial

Identifier Type: -

Identifier Source: org_study_id