Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
Phrase: IV Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD) Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium bromide for relieving dyspnea symptom of COPD Design: a multi-centre randomized parallel blank control study Case number: test group 80, control group 80, totally 160 Site number:7 Study period: 2010.9 - 2011.8
Interventions
DRUGtulobuterol
patch, 2mg, qN, 3 months
DRUGTiotropium Bromide
18ug, inhale, qD, 3 months
DRUGtiotropium bromide
18ug, inhale, qD, 3 months
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* people aging from 40 to 80 with self ability of judgment * out-patients diagnosed as stable COPD according to diagnosing and treatment guideline of COPD (2007 edition) by Respiratory Department of Chinese Medical Association * PFT value at screen phase meet the standard as follows: FEV1/FVC \< 70% and FEV1% among 30%-80% 15 mins after inhalation of 400ug Ventolin (i.e., moderate and severe COPD patients ). * people who can use Tiotropium Bromide powder inhalation device * people who join the study voluntarily and sign ICF (Informed Consent Form)
Exclusion criteria
* people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma * AECOPD （acute exacerbation of COPD） * people who got respiratory failure 1 month before the study * people who received oral corticoid treatment 1 month before the study * people who undergo oxygen therapy at home because of respiratory failure * people who are allergic to β2 receptor agonist such as tulobuterol * patients with Skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch * patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist * patients who have undergone pulmonary lobectomy or have tumor * active tuberculosis patients * people who got acute respiratory tract infection in a month or during screening phase * allergic rhinitis patients * glaucoma patients * people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion * gestation, lactation and child-bearing age women who don't agree to take contraceptive measures during the study * people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases. * People who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire. * People who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components. * people who have taken part in other medical clinical trial * other conditions that investigators think not appropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFT values (pulmonary function test, see description below) | 3 months | IC (inspiratory capacity) 、PEF (peak expiratory flow)、FVC (forced vital capacity)、FEV1 (forced expiratory volume in the first second)、%FEV1 (forced expiratory volume in the first second as predicted)、RV (residual volume)、TLC (total lung capacity)、RV/TLC% (residual volume/total lung capacity as percentage), etc. |
| MRC （Medical Research Council） grade | 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| SGRQ （St. George's questionnaire） score | 3 months |
Countries
China
Outcome results
None listed