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NCT Number: NCT01693003

Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pavilhão Pereira Filho, Porto Alegre, Rio Grande do Sul, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol

Drug

150 µg d.o. during the first 3 weeks

Other names: Onbrez Breezhaler®

Tiotropium

Drug

150 µg d.o. during 3 weeks

Other names: Spiriva Respimat®

Primary outcomes

  1. Exercise tolerance

    Time frame: 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 outcomes

  1. Effort-related dyspnea during daily activities

    Time frame: 3 weeks

  2. Airway diameter and volume, and extension of pulmonary emphysema by multidetector helical chest computed tomography

    Time frame: 3 weeks

  3. Oxidative stress before and after exercise tests

    Time frame: 3 weeks

  4. Exercise dyspnea

    Time frame: 3 weeks

    Dyspnea evaluated by Borg scale each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise)

  5. Dynamic pulmonary hyperinflation

    Time frame: 3 weeks

    Inspiratory capacity measured each 2 minutes during high intensity constant load cardiopulmonary exercise test until exhaustion (peak exercise).

Other outcomes

  1. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Other

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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