Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease

NCT06525051 | Completed

• 1 other identifier: GiresunU-PULMONOLOGY-HB-01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to examine the effect of Tiotropium, which is used in the treatment of COPD, on eye symptoms.The study was conducted prospectively. Patients were examined in three groups. Thirty-six patients were included in each group in the study. Anterior chamber parameters, intraocular pressure values, and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.

Conditions

Chronic Obstructive Pulmonary Disease; Glaucoma, Angle-Closure

Keywords

COPD; Eye findings; Tiotropium; Intraocular pressure; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Tiotropium causes narrowing of the eye angles and an increase in intraocular pressure and pupil diameters.

  Tiotropium 18 mcg is a long-acting anticholinergic drug used in the treatment of COPD. In patients diagnosed with COPD who do not receive any steroid treatment and who are not diagnosed with hypertension, glaucoma, diabetes mellitus, cataract and who have not undergone eye surgery and using only handhaler Tiotropium 18 microgram, a narrowing of the eye angles, an increase in photopic-mesopic pupil diameters and intraocular pressure were detected in the third month of treatment.

  Measurements were made in the third month of Tiotropium treatment.

Secondary Outcomes (1)

• Tiotropium did not cause acute angle-closure glaucoma in COPD patients.

  Measurements were made in the third month of Tiotropium treatment.

Study Arms (3)

Group 1

Group 1 consisted of COPD patients not receiving any treatment ( inhaled and/or systemic steroids, long-acting inhaled beta-2 agonists alone, theophylline and combined long-acting beta-2 agonists and long-acting anticholinergic ). These patients are early stage COPD patients.

Group 2

Group 2 consisted of healthy volunteers for similar age and gender.

Group 3

Group 3 consisted of COPD patients of the same age and gender with receiving only handhaler Tiotropium 18 mcg for three months.

Drug: Tiotropium

Interventions

Tiotropium DRUG

Tiotropium is a long-acting anticholinergic agent and has a bronchodilator effect. According to the COPD Gold 2024 guideline, it is one of the long-acting bronchodilator drugs used as the first choice in the treatment of group A COPD patients.

Group 3

Eligibility Criteria

• Age: 47 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three groups were formed for the study. Group 1 consisted of COPD patients not receiving treatment, Group 2 consisted of healthy volunteers for similar age and gender, and Group 3 consisted of COPD patients of the same age and gender with receiving handhaler Tiotropium 18 mcg. Anterior chamber parameters, intraocular pressure values and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.

You may qualify if:

• Clinical diagnosis of COPD
• Not receiving any COPD treatment
• Receiving only 18 mcg Tiotropium treatment
• With written consent

You may not qualify if:

• \. Patients under 18 years of age 2. Pregnant women 3. Without written consent 4. Receiving the following medications: 4a. Inhaled and/or systemic steroids 4b. Long-acting inhaled beta-2 agonists 4c. Combined long-acting beta-2 agonists and long-acting anticholinergics 4d. Topical medication
• \. Patients with the following comorbidities 5a. Glaucoma 5b. Cataract 5c. Hypertension 5d. Diabetes Mellitus 5e. Patients had previously undergone eyelid, refractive, or intraocular surgery, those with corneal diseases altering the corneal surface
• \. Patients receiving topical medications for chronic eye diseases 7. Patients receiving medications for diabetes mellitus 8. Patients receiving medications for hypertension 8. Patients those using contact lenses

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Training and Research Hospital

Giresun, Gi̇resun, 28100, Turkey (Türkiye)

Location

Related Publications (1)

• Aksoy HB, Koc H. Effect of Tiotropium on eye findings in the treatment of chronic obstructive pulmonary disease. BMC Pulm Med. 2024 Aug 28;24(1):418. doi: 10.1186/s12890-024-03240-1.

  PMID: 39198799 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Glaucoma, Angle-Closure; Eye Manifestations; Glaucoma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 29, 2024
• Study Start: October 23, 2023
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

TU (1)