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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465906
Recruitment Status : Unknown
Verified November 2011 by Chunxue Bai, Shanghai Zhongshan Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2011
Last Update Posted : November 9, 2011
Information provided by (Responsible Party):
Chunxue Bai, Shanghai Zhongshan Hospital

October 28, 2011
November 7, 2011
November 9, 2011
November 2010
November 2011   (Final data collection date for primary outcome measure)
  • PFT values (pulmonary function test, see description below) [ Time Frame: 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 [ Time Frame: 3 months ]
  • PFT values (see description below) [ Time Frame: 3 months ]
  • MRC grade [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01465906 on Archive Site
SGRQ (St. George's questionnaire) score [ Time Frame: 3 months ]
SGRQ score [ Time Frame: 3 months ]
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Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
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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

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: tulobuterol
    patch, 2mg, qN, 3 months
  • Drug: Tiotropium Bromide
    18ug, inhale, qD, 3 months
  • Drug: tiotropium bromide
    18ug, inhale, qD, 3 months
  • Experimental: tulobuterol combined with tiotropium bromide
    • Drug: tulobuterol
    • Drug: tiotropium bromide
  • Active Comparator: Tiotropium bromide
    Intervention: Drug: Tiotropium Bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Chunxue Bai, Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
Not Provided
Principal Investigator: Chunxue Bai, doctor Fudan University
Shanghai Zhongshan Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP