Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive; Chronic Bronchitis; Pulmonary Emphysema
Intervention: Formoterol plus Placebo (Tiotropium) (Drug); Formoterol plus Tiotropium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): J Alberto Neder, MD, phD, Principal Investigator, Affiliation: Federal University of Sao Paulo
Summary
The primary objective is to comparatively evaluate the isolated effects of a long-acting
beta2-adrenergic (formoterol fumarate 12µg b. i.d. via Aeroliser) and combined with a
long-acting anti-cholinergic (tiotropium bromide 18µg o. d via Handihaler) on breathlessness,
dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic
obstructive pulmonary disease. The study hypothesis is that combining long acting
bronchodilators with different action mechanisms would promote synergistic effects on
clinical outcomes.
Clinical Details
Official title: Randomised Cross-over Study to Compare the Effect of Formoterol Plus Tiotropium Versus Formoterol Monotherapy on Breathlessness, Dynamic Hyperinflation and Exercise Tolerance in Moderate-to-severe Stable COPD Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage Change in Exercise Tolerance From Baseline at 2 Weeks
Secondary outcome: Mean Score on the Transitional Dyspnea Index (TDI)
Detailed description:
This will be a single center, randomized, double-blind study consisting of two 2-week
treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators.
Eligible patients who complete the one week screening phase will be randomized to one of two
treatment sequences: 1) Formoterol - -> Formoterol + Tiotropium or 2) Formoterol + Tiotropium
- -> Formoterol. During the treatment periods, patients will be allowed to use a short-acting
beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium
via MDI)
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- COPD patients aged ≥ 40 years with stable moderate-to-severe airflow obstruction
(FEV1 < 70% and FEV1/FVC ≤ 70% of predicted normal value) post-bronchodilator
- presenting with a long history of smoking (> 20 pack-years) and chronic
breathlessness (Baseline Dyspnoea Index total score < 9)
Exclusion Criteria:
- significant cardiovascular disease, hospitalization for COPD exacerbation or presence
of a respiratory tract infection within 1 month of screening
- current or childhood asthma
- a history of allergic rhinitis or other atopic disease
- inability to interrupt usual bronchodilator medication
- use of oral steroids within a month before screening
- need for long-term oxygen therapy, arterial oxygen saturation < 85% at rest anemia,
hypo- and hyperthyroidism, hyperadrenergic state
- uncontrolled insulin dependent diabetes mellitus, malignancy, or any disease or
condition which limits exercise performance other than COPD
- change in inhaled corticosteroid or theophylline use within 1 month prior to
screening
Locations and Contacts
Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Sao Paulo 04020-050, Brazil
Additional Information
Starting date: November 2007
Last updated: January 12, 2010
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