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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shanghai Zhongshan Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Chunxue Bai, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01465906
First received: October 28, 2011
Last updated: November 8, 2011
Last verified: November 2011

October 28, 2011
November 8, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • PFT values (see description below) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    IC 、PEF、FVC、FEV1、%FEV1、RV、TLC、RV/TLC%, etc.
  • MRC grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01465906 on ClinicalTrials.gov Archive Site
SGRQ (St. George's questionnaire) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
SGRQ score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
Not Provided

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01465906
TG1015TLT
Yes
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