Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease

• Status: Unknown status
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Bromides; Terbutaline; Tiotropium Bromide; Tulobuterol

Criteria

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