Phase 4
Completed N=33
Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients
Pulmonary Disease, Chronic Obstructive · bronchitis · Pulmonary Emphysema
Source: ClinicalTrials.gov NCT00680056 ↗
Enrolled (actual)
33
Serious AEs
—
Results posted
Dec 2009
Primary outcomePrimary: Percentage Change in Exercise Tolerance From Baseline at 2 Weeks — 68; 124 Percentage change — p=0.038
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Exercise Tolerance From Baseline at 2 Weeks |
68; 124 | 0.038 sig |
| SECONDARY Mean Score on the Transitional Dyspnea Index (TDI) |
2.9; 3.8 | 0.054 |
Eligibility Criteria
Inclusion Criteria
- COPD patients aged ≥ 40 years with stable moderate-to-severe airflow obstruction (FEV1 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
Data sourced from ClinicalTrials.gov (NCT00680056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.