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

NCT01465906 | Unknown Phase 4 DMC

• 1 other identifier: TG1015TLT
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• SGRQ （St. George's questionnaire） score

  3 months

Study Arms (2)

tulobuterol combined with tiotropium bromide

EXPERIMENTAL

Drug: tulobuterol; Drug: tiotropium bromide

Tiotropium bromide

ACTIVE COMPARATOR

Drug: Tiotropium Bromide

Interventions

tulobuterol DRUG

patch, 2mg, qN, 3 months

tulobuterol combined with tiotropium bromide

tiotropium bromide DRUG

18ug, inhale, qD, 3 months

Tiotropium bromide

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tulobuterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Chunxue Bai, doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Respiratory Department , Shanghai Zhongshan Hospita

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 7, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 9, 2011

Record last verified: 2011-11

Locations

CN (1)