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COPDNCT06674395

Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)

An observational study of COPD, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. The objective of the study is to cross culturally adapt LCQ in Urdu language and to find the reliability and validity in patients of COPD. It is a three-stage study. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COPD
How many people
144 participants
Where
1 sitePakistan
Study dates
1 Feb 2024to 15 Dec 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects with Chronic Obstructive Pulmonary Diseases

Who may be able to join

  • Subjects with GOLD II, III and IV Chronic Obstructive Pulmonary Diseases
  • Having age18 years or more
  • subjects having chronic cough (> 8 weeks)
  • Subjects understanding Urdu

Who cannot join

  • A previous history of other lung disorders
  • Pregnant females, subjects having Infections
  • Any systemic disorder which is unstable
  • Subjects who are not willing to participate
  • subject with Cognitive \& speech disorders

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Gujranwala Medical College Teaching Hospital

    Gujranwala, Punjab Province

Other trials in Pakistan

About this study

Official title: Cross Cultural Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)

Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. The objective of the study is to cross culturally adapt LCQ in Urdu language and to find the reliability and validity in patients of COPD.

It is a three-stage study. Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI).

Read more

In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD.

114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Read the detailed description

Cough is a common symptom of asthma, COPD, and bronchiectasis, little is known about how it affects health status; therefore any negative effects may go unnoticed in these situations. Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. To the extent of author's knowledge, this widely used Leicester Cough Questionnaire (LCQ) has not been translated and validated for Urdu-speaking patients with COPD.

The objective of the study is to cross culturally adapt LCQ in Urdu language using international guidelines used for translation of instrument from its source language to target language and to find the reliability, validity, sensitivity, and specificity of the Urdu version of Leicester Cough Questionnaire (LCQ) in patients of COPD. It is a three-stage study.

Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI). In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD. 114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Conditions
COPD
Keywords
cough, patient reported outcome measures, pulmonary diseases, validation study, translations
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Cough, Lung Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leicester Cough Questionnaire (LCQ)

    LCQ is a 19-item cough measuring tool, created in 2003 by Birring et al., and it comprised physical, psychological, and social elements.

    Measured: At Baseline and after 1 week

  2. St. George Respiratory Questionnaire

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

    Measured: At Baseline and after 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start1 Feb 2024
  3. Primary completion30 Nov 2024
  4. Study completion15 Dec 2024

Resources

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
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674395
Sponsor's protocol ID
REC/RCR&AHS/24/0316
Status last verified
Jan 2025
First submitted
3 Nov 2024
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Polley L, Yaman N, Heaney L, Cardwell C, Murtagh E, Ramsey J, MacMahon J, Costello RW, McGarvey L. Impact of cough across different chronic respiratory diseases: comparison of two cough-specific health-related quality of life questionnaires. Chest. 2008 Aug;134(2):295-302. doi: 10.1378/chest.07-0141. Epub 2007 Dec 10.

    PubMed 18071022

  • Young EC, Smith JA. Quality of life in patients with chronic cough. Ther Adv Respir Dis. 2010 Feb;4(1):49-55. doi: 10.1177/1753465809358249. Epub 2010 Jan 5.

    PubMed 20051447

  • Wang Z, Wang M, Wen S, Yu L, Xu X. Types and applications of cough-related questionnaires. J Thorac Dis. 2019 Oct;11(10):4379-4388. doi: 10.21037/jtd.2019.09.62.

    PubMed 31737324

  • Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.

    PubMed 12668799

  • Huisman AN, Wu MZ, Uil SM, van den Berg JW. Reliability and validity of a Dutch version of the Leicester Cough Questionnaire. Cough. 2007 Feb 21;3:3. doi: 10.1186/1745-9974-3-3.

    PubMed 17313670

  • Gao YH, Guan WJ, Xu G, Gao Y, Lin ZY, Tang Y, Lin ZM, Li HM, Luo Q, Zhong NS, Birring SS, Chen RC. Validation of the Mandarin Chinese version of the Leicester Cough Questionnaire in bronchiectasis. Int J Tuberc Lung Dis. 2014 Dec;18(12):1431-7. doi: 10.5588/ijtld.14.0195.

    PubMed 25517807

  • Sonnerfors P, Faager G, Einarsson U. Translation of the Leicester Cough Questionnaire into Swedish, and validity and reliability in chronic obstructive pulmonary disease. Disabil Rehabil. 2018 Nov;40(22):2662-2670. doi: 10.1080/09638288.2017.1353648. Epub 2017 Jul 20.

    PubMed 28728439

  • Dabrowska M, Krakowiak K, Radlinska O, Rybka A, Grabczak EM, Maskey-Warzechowska M, Korczynski P, Birring SS, Krenke R. Validation of the Polish Version of the Chronic Cough Quality of Life Questionnaire (Leicester Cough Questionnaire). Adv Clin Exp Med. 2016 Jul-Aug;25(4):649-53. doi: 10.17219/acem/59512.

    PubMed 27629838

  • Kwon JW, Moon JY, Kim SH, Song WJ, Kim MH, Kang MG, Lim KH, Lee SH, Lee SM, Lee JY, Kwon HS, Kim KM, Kim SH, Kim SH, Jeong JW, Kim CW, Cho SH, Lee BJ; Work Group for Chronic Cough, the Korean Academy of Asthma, Allergy and Clinical Immunology. Reliability and validity of a korean version of the leicester cough questionnaire. Allergy Asthma Immunol Res. 2015 May;7(3):230-3. doi: 10.4168/aair.2015.7.3.230. Epub 2014 Dec 18.

    PubMed 25749761

  • Reychler G, Schinckus M, Fremault A, Liistro G, Pieters T. Validation of the French version of the Leicester Cough Questionnaire in chronic obstructive pulmonary disease. Chron Respir Dis. 2015 Nov;12(4):313-9. doi: 10.1177/1479972315602618. Epub 2015 Sep 7.

    PubMed 26346891

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Riphah International University at 1 site in Pakistan.

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 5 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 3 Jan 2025. 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 Pakistan. 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?

Leicester Cough Questionnaire (LCQ) (time frame: At Baseline and after 1 week). The study lists 2 primary outcomes in all. 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 NCT06674395, which also lists 10 linked publications.

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 Jan 2025.

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