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

NCT03842839 — Not applicable, Completed, 84 participants, Guangzhou Institute of Respiratory Disease

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Registry	NCT03842839
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	84 (Actual)
Sponsor	Guangzhou Institute of Respiratory Disease (Other)
Conditions	Airway Remodeling, Chronic Obstructive Pulmonary Disease
Interventions	Tiotropium Inhalation Powder [Spiriva] 0.018mg, Salbutamol sulphate aerosol (Ventolin) 0.1mg (Drug)
Dates	start 2019-08-01, primary completion 2025-05-07, completion 2025-05-07, first posted 2019-02-15, last updated 2026-10-21
Locations	1 site in China

-Summary

This randomized, open-label, three-arm clinical trial evaluated the effects of tiotropium on airway remodeling in patients with GOLD stage 1 COPD using endobronchial optical coherence tomography (EB-OCT). Participants were randomly assigned to receive tiotropium for 12 months followed by withdrawal for months 12-24, tiotropium continuously for 24 months, or SABA as needed without regular long-acting bronchodilator therapy. Airway morphology, pulmonary function, impulse oscillometry, and SABA use were assessed during the 24-month follow-up.

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+Arms and interventions

Arm	Type	Interventions	Description
Tiotropium (0-12 month) + SABA as needed	Experimental	Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg	* During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months. * Scheduled tiotropium treatment was discontinued after month 12. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded. * Salbutamol sulphate aerosol (Ventolin) was available as needed for symptom relief throughout the 24-month follow-up.
Tiotropium (0-24 month) + SABA as needed	Experimental	Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg	* 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) was available as needed for symptom relief throughout the 24-month follow-up.
SABA as needed only	Other	Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg	* During the 24-month study period, salbutamol inhalation aerosol (Ventolin) was available as needed for symptom relief. * No scheduled long-acting bronchodilator was assigned in this group. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded.

Tiotropium Inhalation Powder [Spiriva] 0.018mg (Drug), also known as Spiriva: Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
Salbutamol sulphate aerosol (Ventolin) 0.1mg (Drug), also known as Ventolin: Salbutamol inhalation aerosol (Ventolin), 100 μg per actuation, was available as needed for symptom relief throughout the 24-month study period.

+Outcome measures

Primary outcomes

Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 24 [Baseline and month 24]: To evaluate the effects of tiotropium on structural remodeling of small airways in patients with early-stage COPD.

Secondary outcomes

Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 12 [Baseline and Month 12]: Change from baseline to month 12 in patient-level mean airway luminal area of generations 7-9, measured by EB-OCT (mm²).
Change from baseline in inner luminal area (Ai) of 3rd-6th generation bronchi [Baseline, Month 12, and Month 24]: To evaluate the effects of tiotropium on structural remodeling of medium-sized airways in patients with early-stage COPD.
Change from baseline in the airway wall area percentage (Aw%) of the 7th to 9th generation bronchi [Baseline, Month 12, and Month 24]: To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Change from baseline in the airway wall area percentage (Aw%) of the 3rd to 6th generation bronchi [Baseline, Month 12, and Month 24]: To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Change from baseline in trough FEV1 [Baseline, Month 12, and Month 24]: To evaluate the effects of Tiotropium in improving lung function
Change from baseline in peripheral airway resistance (R5-R20) [Baseline, Month 12, and Month 24]: To evaluate the effects of Tiotropium in improving lung function
Change from baseline in COPD Assessment Test (CAT) score [Baseline, Month 12, and Month 24]: Change from baseline in COPD Assessment Test (CAT) score

Other outcomes

Changes from baseline in parametric response mapping-defined functional small-airway disease and emphysema [Baseline, month 12 and month 24]: Changes from baseline in parametric response mapping-defined functional small-airway disease and emphysema
Proportion of participants experiencing at least one COPD exacerbation during 24 months [Baseline to Month 24]: Proportion of participants experiencing at least one COPD exacerbation during the 24-month follow-up.

+Eligibility

Sex: All, ages: 40 Years to 80 Years

Key inclusion criteria

* Over 40 yrs; Male or female Diagnosed with COPD
* Post-bronchodilator FEV1/FVC <0.70 and FEV1 ≥80% predicted;
* 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.

+Locations (1)

Facility	City	Country	Status
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou, Guangdong	China

+Investigators

Shiyue Li, MD, Principal investigator, Guangzhou Institute of Respiratory Health