Outpatients of Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Spiriva Respimat as a marketed product dose: 5mcg once daily in the morning duration of treatment 8weeks
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients of either sex, 40 years or older, 2) Diagnosis of COPD, having prolonged sputum. 3) Cigarette smoking history of &#8805; 20 pack-years 4) FEV1 < = 80% of predicted normal Predicted normal values will be calculated as follows: Males: FEV1.0 predicted (L) = 0.036 x (height (cm)) &#8211; 0.028 x age (years) &#8211; 1.178 Females: FEV1.0 predicted (L) = 0.022 x (height (cm)) &#8211; 0.022 x age (years) &#8211; 0.005 5) FEV1 &#8804; 70% of FVC 6) Patients who had been continuously expectorating more than 30 g of sputum/day for at least two weeks 7) Patients who were judged to be eligible for enrollment by the investigator 8) Written Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Patients whose dose of antibiotics, steroid, &#61538;2 stimulant, anti-cholinergic agent, theophylline preparation or expectorant was changed within 1 month before the screening test. 2) Patients who began treatment with an ACE inhibitor or whose dose of ACE inhibitor was changed within 1 month before the screening test. 3) Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test). 4) Patients with a history of hypersensitivity to the components of Tiotropium Respimat 5) Patients with contraindication of Tiotropium Respimat. 6) Other than the above, patients judged by the investigator to be inappropriate as the subjects of study. 7) Patients with alcohol or drug abuse. 8) Patients who are unable to utilize spirometry 9) Patients who were judged not to be eligible for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation: Cough and Sputum Assessment Questionnaire (CASA-Q). | — |
Countries
Japan
Contacts
Public ContactJun Tamaoki
Tokyo Women's Medical University First Department of Medicine
Outcome results
None listed