Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography

Guangzhou Institute of Respiratory Disease

Status: Enrolling

Conditions: Airway Remodeling

Treatments: Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03842839

ESCOPD-20181001

Details and patient eligibility

About

The study aims to explore the effect of tiotropium on airway remodeling by using Endobronchial Optical Coherence Tomography (EB-OCT). We enrolled patients with GOLD I stage COPD. All the patients will be divided into four groups randomly to receive SABA as needed with or without regular use of tiotropium. Changes of airway morphology (accessed by EB-OCT), pulmonary function, QOL, and SABA usage will be obtained.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria

• Over 40 yrs; Male or female Diagnosed with COPD
• Pre-bronchodilator FEV1 ≥80% pred ;
• Patients must be able to perform all study related procedures

Exclusion Criteria:

• Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).
• Patients have poor compliance and are unwilling to receive medication regularly.
• Other complications of bronchoscopy or intolerance of bronchoscopy procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Tiotropium (0-12 month) + SABA as needed

Experimental group

Description:

* During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months. * Any long acting bronchodilator will not be used from the 12 to 24 months. * Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.

Treatment:

Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg

Tiotropium (0-24 month) + SABA as needed

Experimental group

Description:

* During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 24th months. * Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.

Treatment:

Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg

SABA as needed only

Other group

Description:

* During the 2 years treatment phase patients will be administered with salbutamol sulphate aerosol (Ventolin) when exacerbation occurs. * Any long acting bronchodilator will not be used during the 2 years treatment phase.

Treatment:

Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg