Airway Effects of Tiotropium in Patients With COPD
Condition: COPD; LUNG DISEASES, OBSTRUCTIVE
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Intervention: Handihaler-Tiotropium 18 mcg untrained; Handihaler-Tiotropium 18 mcg trained; Respimat-Tiotropium 5 mcg trained
Intervention description: We are looking at the untrained used of Handihaler; We are looking at the trained use of Handihaler after 14 days treatment; we are looking at the trained use of Respimat after 14 days treatment
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Each volunteer get all treatment in a same sequence
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Inhalers; Tiotropium

Summary:

      The aim of the study is to investigate the effect of tiotropium from different devices on a
      panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with
      mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18 micrograms once
      daily and Tiotropium Respimat 5 micrograms once daily
    

Eligibility criteria:

        Inclusion Criteria:

          1. COPD patients with FEV1/FVC <70% predicted.

          2. Mild (GOLD stage I: FEV1 >80% pred.) to moderate (GOLD stage II: FEV1 50-80% pred.)

          3. Aged 30 years onwards - there is no upper age limit as we do not want to exclude
             elderly patients as COPD is primarily a disease in the elderly population.

          4. Have on-going symptoms or exercise limitation (determined by CAT score)

          5. Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past
             2 months).

          6. Capable of giving informed consent, which includes compliance with the requirements
             and restrictions listed in the consent form.

        Exclusion Criteria:

          1. Subjects who lack the capacity to consent will not be recruited.

          2. Current or past diagnosis of asthma.

          3. Patients on concurrent oral bronchodilators (theophylline, PDE4 inhibitors) will not
             be included.

          4. Patients on other LAMAs will not be included

          5. History of any chronic respiratory diseases other than COPD.

          6. History of another medical condition, which in the opinion of the Unit Physician,
             contraindicates his/her participation in the study.

          7. Clinical evidence of heart failure (NYHA class III-IV).

          8. Unstable respiratory disease in the last four weeks prior to the screening visit
             (indicated by any change in their maintenance inhaled therapy or who have had a lower
             respiratory tract infection in the previous four weeks).

          9. Evidence of a respiratory exacerbation requiring emergency room treatment and/or
             hospitalisation within four weeks before screening.

         10. Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable
             depot steroids 6 weeks) or more than 3 periods during the last 12 months.

         11. Participants with a known or suspected allergy, sensitivity or intolerance to the
             study drugs (this will be asked directly at the screening visit) or patients with a
             history of another drug allergy which, in the opinion of the Unit Physician,
             contraindicates his/her participation in the study.

         12. Patients with known or suspected cardiac rhythm disorders

         13. Patients treated with beta-blockers in the week preceding the screening visit and
             during the study period.

         14. Females who are pregnant or lactating or are likely to become pregnant during the
             trial. (a urine pregnancy test will be performed. Women of childbearing potential may
             be included in the study if, in the opinion of the investigator, they are taking
             adequate contraceptive precautions.

         15. Patients who have evidence of alcohol or substance abuse.

         16. Participation in another clinical trial with an investigational drug in the four weeks
             preceding the screening visit.