Clinical trial NCT01465906: Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: PFT values (pulmonary function test, see description below)
timeFrame: 3 months
measure: MRC （Medical Research Council） grade
timeFrame: 3 months
Secondary outcomes:
measure: SGRQ （St. George's questionnaire） score
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Chunxue Bai, doctor
role: PRINCIPAL_INVESTIGATOR
References: