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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01465906
• Other study ID #: TG1015TLT
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 28, 2011
• Last updated: November 8, 2011
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 ß2 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 useß2 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tulobuterol
patch, 2mg, qN, 3 months
• Tiotropium Bromide
18ug, inhale, qD, 3 months
• tiotropium bromide
18ug, inhale, qD, 3 months

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	MRC (Medical Research Council) grade		3 months	No
Secondary	SGRQ (St. George's questionnaire) score		3 months	No