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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: tulobuterol; Drug: tiotropium bromide; Drug: Tiotropium Bromide

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tulobuterol combined with tiotropium bromide	Drug: tulobuterol; patch, 2mg, qN, 3 months; Drug: tiotropium bromide; 18ug, inhale, qD, 3 months
Active Comparator: Tiotropium bromide	Drug: Tiotropium Bromide; 18ug, inhale, qD, 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFT values (pulmonary function test, see description below)	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.	3 months
MRC （Medical Research Council） grade		3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
SGRQ （St. George's questionnaire） score	3 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Chunxue Bai, doctor, Fudan University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 6, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Tiotropium Bromide; Bromides; Tulobuterol
• Other Study ID Numbers: TG1015TLT