Status:
COMPLETED
Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients
Lead Sponsor:
Federal University of São Paulo
Conditions:
Pulmonary Disease, Chronic Obstructive
Chronic Bronchitis
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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-cholinerg...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00680056
Start Date
November 1 2007
End Date
January 1 2009
Last Update
January 20 2010
Active Locations (1)
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1
Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE)
São Paulo, São Paulo, Brazil, 04020-050