Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01465906
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01465906
Study Brief:
Protocol Section:
NCT01465906