Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

NCT01693003 | Completed Phase 4

• 1 other identifier: ISCMPALABAtrial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Oxidative stress before and after exercise tests

  3 weeks

• Exercise dyspnea

  3 weeks

• Dynamic pulmonary hyperinflation

  3 weeks

Other Outcomes (1)

• Adverse events

  Participants will register adverse events in clinical research diaries or communicate to investigator during 3-week treatment period

Study Arms (2)

Indacaterol first

EXPERIMENTAL

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

Drug: Indacaterol; Drug: Tiotropium

Tiotropium first

EXPERIMENTAL

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

Drug: Indacaterol; Drug: Tiotropium

Interventions

Indacaterol DRUG

150 µg d.o. during the first 3 weeks

Also known as: Onbrez Breezhaler®

Indacaterol first; Tiotropium first

Tiotropium DRUG

150 µg d.o. during 3 weeks

Also known as: Spiriva Respimat®

Indacaterol first; Tiotropium first

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Irmandade Santa Casa de Misericórdia de Porto Alegre: lead
• Novartis: collaborator

Study Sites (2)

Pavilhão Pereira Filho

Porto Alegre, Rio Grande do Sul, 90002-090, Brazil

Location

Pavilhão Pereira Filho

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27812637 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Paulo Z Teixeira, MD

  Santa Casa de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor and chair of the study

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

BR (2)