Chronic Obstructive Pulmonary DiseaseNCT06525051
Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Glaucoma, Angle-Closure, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 47 to 82 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Glaucoma, Angle-Closure
- What is being tested?
- Tiotropium
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of COPD
- Not receiving any COPD treatment
- Receiving only 18 mcg Tiotropium treatment
- With written consent
Who cannot join
- 1. 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
- 5. 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
- 6. 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Training and Research Hospital
Giresun, Gi̇resun, 28100
About this study
Official title: Examination of the Effect of Handhaler Tiotropium, a Long-acting Anticholinergic, on Anterior Chamber Parameters
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a persistent, chronic inflammatory disease of the lungs. Tiotropium, used in the treatment of COPD, is a muscarinic receptor antagonist that provides long-acting bronchodilation. In this study the researchers aimed to investigate the effects of Tiotropium on eye anterior chamber parameters.
The study was conducted prospectively between October 2023 and April 2024 after obtaining local Ethics Committee approval (Giresun EAH KEAK 2023/180 and 9.10.2023/02). Patients diagnosed with COPD and included in Group A according to the GOLD 2024 guidelines, along with healthy volunteers, were enrolled. Patients diagnosed with COPD, with mMRC scale 0-1, CAT score <10, who had never experienced an exacerbation before or had a mild severity exacerbation once that not required hospitalization were considered as Group A. Patients were examined in three groups: 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 Tiotropium 18 mcg Handihaler. A total of 108 patients, 36 patients in each group, were included 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.
Anterior segment optical coherence tomography (AS-OCT) was used to measure anterior chamber and angle parameters, corneal topography was utilized to assess anterior chamber depth, pupil diameter measurements in mesopic and photopic conditions, and intraocular pressure (IOP) was calculated using Goldmann applanation tonometry. Each patient underwent a comprehensive ophthalmic evaluation, including testing of best-corrected visual acuity, slit-lamp biomicroscopy, and fundoscopic examination.
Corneal topography (Topcon Aladdin Corneal Topography, Japan) was used to evaluate anterior chamber depth and pupil diameter in mesopic and photopic conditions. Pupil diameters measured with corneal topography were obtained by the same researcher, using the same device, at the same times of day and under similar lighting conditions.
Intraocular pressure was measured using Goldman Applanation tonometry. All measurements were conducted by the same researcher around 10 a.m., using the same tonometer device, without any manipulation or negligible manipulation of the eyelids. Applanation was performed by rotating the dial on the Goldman tonometer previously set to 10 mm Hg. The procedure was repeated after one minute. If the difference between the first and second readings was greater than 2 mm Hg, a third reading was performed. The average of the data obtained from two readings was taken, and if a third reading was needed, the median was used instead.
This study is the first research that investigate the effects of Tiotropium on anterior chamber parameters, pupil diameters, and intraocular pressure in COPD treatment.
- Being tested
- Tiotropium
- Keywords
- COPD, Eye findings, Tiotropium, Intraocular pressure, Glaucoma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Glaucoma, Angle-Closure, Eye Manifestations, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements were made in the third month of Tiotropium treatment.
Secondary outcomes (1)
Tiotropium did not cause acute angle-closure glaucoma in COPD patients.
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 ) using only handhaler Tiotropium 18 microgram, open angle-closure glaucoma was not observed.
Measured: Measurements were made in the third month of Tiotropium treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start23 Oct 2023
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayriye Bektaş, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525051
- Sponsor's protocol ID
- GiresunU-PULMONOLOGY-HB-01
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39198799
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effect of Handhaler Tiotropium, a Long-acting Anticholinergic, on Anterior Chamber Parameters
- ClinicalTrials.gov ID
- NCT06525051
- Acronym / sponsor ID
- GiresunU-PULMONOLOGY-HB-01
- Keywords
- COPD, Eye findings, Tiotropium, Intraocular pressure, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a persistent, chronic inflammatory disease of the lungs. Tiotropium, used in the treatment of COPD, is a muscarinic receptor antagonist that provides long-acting bronchodilation. In this study the researchers aimed to investigate the effects of Tiotropium on eye anterior chamber parameters.
The study was conducted prospectively between October 2023 and April 2024 after obtaining local Ethics Committee approval (Giresun EAH KEAK 2023/180 and 9.10.2023/02). Patients diagnosed with COPD and included in Group A according to the GOLD 2024 guidelines, along with healthy volunteers, were enrolled. Patients diagnosed with COPD, with mMRC scale 0-1, CAT score <10, who had never experienced an exacerbation before or had a mild severity exacerbation once that not required hospitalization were considered as Group A. Patients were examined in three groups: 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 Tiotropium 18 mcg Handihaler. A total of 108 patients, 36 patients in each group, were included 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.
Anterior segment optical coherence tomography (AS-OCT) was used to measure anterior chamber and angle parameters, corneal topography was utilized to assess anterior chamber depth, pupil diameter measurements in mesopic and photopic conditions, and intraocular pressure (IOP) was calculated using Goldmann applanation tonometry. Each patient underwent a comprehensive ophthalmic evaluation, including testing of best-corrected visual acuity, slit-lamp biomicroscopy, and fundoscopic examination.
Corneal topography (Topcon Aladdin Corneal Topography, Japan) was used to evaluate anterior chamber depth and pupil diameter in mesopic and photopic conditions. Pupil diameters measured with corneal topography were obtained by the same researcher, using the same device, at the same times of day and under similar lighting conditions.
Intraocular pressure was measured using Goldman Applanation tonometry. All measurements were conducted by the same researcher around 10 a.m., using the same tonometer device, without any manipulation or negligible manipulation of the eyelids. Applanation was performed by rotating the dial on the Goldman tonometer previously set to 10 mm Hg. The procedure was repeated after one minute. If the difference between the first and second readings was greater than 2 mm Hg, a third reading was performed. The average of the data obtained from two readings was taken, and if a third reading was needed, the median was used instead.
This study is the first research that investigate the effects of Tiotropium on anterior chamber parameters, pupil diameters, and intraocular pressure in COPD treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: TiotropiumGroup 3 consisted of COPD patients of the same age and gender with receiving only handhaler Tiotropium 18 mcg for three months. |
Who may qualify
- Ages
- 47 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Clinical diagnosis of COPD
- Not receiving any COPD treatment
- Receiving only 18 mcg Tiotropium treatment
- With written consent
Key exclusion criteria (3 listed)
- 1. 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
- 5. 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
- 6. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumTiotropium 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. | Drug | Group 3 |
Primary outcome
Tiotropium causes narrowing of the eye angles and an increase in intraocular pressure and pupil diameters.
Time frame: Measurements were made in the third month of Tiotropium treatment.
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.
1 secondary outcome
Tiotropium did not cause acute angle-closure glaucoma in COPD patients.
Time frame: Measurements were made in the third month of Tiotropium treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 39198799Aksoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Glaucoma, Angle-Closure, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tiotropium causes narrowing of the eye angles and an increase in intraocular pressure and pupil diameters. (time frame: Measurements were made in the third month of Tiotropium treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.