Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients
Condition: Pulmonary Disease, Chronic Obstructive; Chronic Bronchitis; Pulmonary Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Chronic Disease; Emphysema
Intervention: Formoterol plus Placebo (Tiotropium); Formoterol plus Tiotropium
Intervention description: Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.; Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.
Intervention MeSH terms: Formoterol Fumarate; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Pulmonary Disease, Chronic Obstructive; Tiotropium; Formoterol; Bronchodilator Agents; Exercise Tolerance; Randomized Controlled Trial [Publication Type]; COPD

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.
    

Eligibility 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