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

Phase 4

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: tulobuterol; Drug: tiotropium bromide

• Registration Number: NCT01465906
• Lead Sponsor: Shanghai Zhongshan Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-10-28
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-06
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tulobuterol combined with tiotropium bromide	tiotropium bromide	-
Tiotropium bromide	tiotropium bromide	-
tulobuterol combined with tiotropium bromide	tulobuterol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
SGRQ （St. George's questionnaire） score	3 months

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China