COPD (Chronic Obstructive Pulmonary Disease)NCT07261813
Chronic Obstructive Pulmonary Disease, Quality of Life, COPD Assessment Test, Nepal, Dyspnea, Spirometry
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Quality of Life, run by Institute of medicine, Maharagjung medical campus.
Trial summary
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. The study "Quality of life among people living with Chronic Obstructive Pulmonary Disease- visiting spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal" aims to assess the quality… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Quality of Life
- What is being tested?
- Evaluation of Quality of life in COPD patients
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study enrolled participants aged 20 years or older who were referred to the spirometry center of Tribhuvan University Teaching Hospital. The primary inclusion criterion was a confirmed diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, defined as a postbronchodilator ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) < 0.70.
Who may be able to join
- Age ≥ 20 years
- Referred to the spirometry center of Tribhuvan University Teaching Hospital
- Confirmed diagnosis of COPD based on GOLD criteria: post-bronchodilator FEV1/FVC < 0.7
Who cannot join
- Unable to perform acceptable spirometry maneuvers
- Presence of significant respiratory diseases that can confound COPD assessment (e.g., asthma, bronchiectasis, active tuberculosis)
About this study
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. The study "Quality of life among people living with Chronic Obstructive Pulmonary Disease- visiting spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal" aims to assess the quality of life (QOL) of COPD patients and the factors affecting it.
A cross sectional study will be performed among the patients visiting Spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal using Convenience Sampling. Ethical approval will be obtained from Institutional Review Board (IRB) of TUTH and written/verbal consent for data collection will be obtained from Teaching hospital authority as well as the respondents. CAT questionnaire will be used to assess quality of life and the Medical Research Council questionnaire will be used to assess the severity of dyspnea. Data management and analysis will be conducted through Statistical Package for Social Sciences (SPSS) version 26.0.
- Being tested
- Evaluation of Quality of life in COPD patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Quality of life in COPD patientsOther
This study does not involve a clinical intervention. Instead, it focuses on evaluating Quality of life of COPD patient using the COPD Assessment Test (CAT). It is a validated, patient-completed questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It consists of eight simple questions, each scored from 0 to 5, covering symptoms such as cough, sputum production, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep quality, and energy levels. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD on the patient's daily life. A score of 0-10 suggests a low impact, 11-20 a medium impact, 21-30 a high impact, and 31-40 a very high impact. The CAT is easy to administer, typically taking less than two minutes to complete, and provides clinicians with a standardized way to monitor disease progression and evaluate treatment effectiveness.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQoL) Score (COPD Assessment Test - CAT)
The COPD Assessment Test (CAT) score ranges from 0 to 40, with 0 indicating no impact and 40 indicating the worst impact on quality of life. Higher scores represent worse outcomes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Institute of medicine, Maharagjung medical campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhishek Kumar Shah, Institute of medicine, Maharagjung medical campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261813
- Sponsor's protocol ID
- 353 (6-11) E2 077/ 078
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is an observational study focused on evaluating the quality of life of COPD patients, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease, Quality of Life, COPD Assessment Test, Nepal, Dyspnea, Spirometry
- ClinicalTrials.gov ID
- NCT07261813
- Acronym / sponsor ID
- 353 (6-11) E2 077/ 078
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Institute of medicine, Maharagjung medical campusUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. The study "Quality of life among people living with Chronic Obstructive Pulmonary Disease- visiting spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal" aims to assess the quality of life (QOL) of COPD patients and the factors affecting it.
A cross sectional study will be performed among the patients visiting Spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal using Convenience Sampling. Ethical approval will be obtained from Institutional Review Board (IRB) of TUTH and written/verbal consent for data collection will be obtained from Teaching hospital authority as well as the respondents. CAT questionnaire will be used to assess quality of life and the Medical Research Council questionnaire will be used to assess the severity of dyspnea. Data management and analysis will be conducted through Statistical Package for Social Sciences (SPSS) version 26.0.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study enrolled participants aged 20 years or older who were referred to the spirometry center of Tribhuvan University Teaching Hospital. The primary inclusion criterion was a confirmed diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, defined as a postbronchodilator ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) < 0.70.
Key inclusion criteria (3 listed)
- Age ≥ 20 years
- Referred to the spirometry center of Tribhuvan University Teaching Hospital
- Confirmed diagnosis of COPD based on GOLD criteria: post-bronchodilator FEV1/FVC < 0.7
Key exclusion criteria (2 listed)
- Unable to perform acceptable spirometry maneuvers
- Presence of significant respiratory diseases that can confound COPD assessment (e.g., asthma, bronchiectasis, active tuberculosis)
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 |
|---|---|---|
| Evaluation of Quality of life in COPD patientsThis study does not involve a clinical intervention. Instead, it focuses on evaluating Quality of life of COPD patient using the COPD Assessment Test (CAT). It is a validated, patient-completed questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It consists of eight simple questions, each scored from 0 to 5, covering symptoms such as cough, sputum production, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep quality, and energy levels. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD on the patient's daily life. A score of 0-10 suggests a low impact, 11-20 a medium impact, 21-30 a high impact, and 31-40 a very high impact. The CAT is easy to administer, typically taking less than two minutes to complete, and provides clinicians with a standardized way to monitor disease progression and evaluate treatment effectiveness. | Other | – |
Primary outcome
Health-Related Quality of Life (HRQoL) Score (COPD Assessment Test - CAT)
Time frame: 1 month
The COPD Assessment Test (CAT) score ranges from 0 to 40, with 0 indicating no impact and 40 indicating the worst impact on quality of life. Higher scores represent worse outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. Since this is an observational study focused on evaluating the quality of life of COPD patients, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Quality of Life, run by Institute of medicine, Maharagjung medical campus.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Health-Related Quality of Life (HRQoL) Score (COPD Assessment Test - CAT) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.