A study to accurately define reflux in patients with chronic cough
| ISRCTN | ISRCTN62337037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62337037 |
| Protocol serial number | 2005TM011 (R&D) |
| Sponsor | University Hospital of South Manchester (UK) |
| Funder | Moulton Charitable Trust (UK) |
- Submission date
- 23/08/2010
- Registration date
- 13/09/2010
- Last edited
- 11/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jaclyn Ann Smith
Scientific
Scientific
School of Translational Medicine
University Hospital of South Manchester
2nd Floor, Education & Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational cross sectional cohort study running over 3 years. |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | A study to accurately define gastro-oesophageal reflux disease in patients with chronic cough: An observational, cross-sectional cohort study |
| Study acronym | SD/AK GORD |
| Study objectives | We hypothesise that both acid and non acid reflux events cause chronic cough in patients with chronic cough. This hypothesis would explain why acid suppressing treatments are only successful in half of patients with proven acid reflux. To date no investigators have used all available techniques to define reflux events in patients with chronic cough as acid/non-acid, proximal/distal. The proximity of the reflux (larynx/pharynx or distal oesophagus) may be important. Further reading: 1. S. Decalmer, D. Webster, A. Kelsall, K McGuiness, A. Woodcock, J.A. Smith. Chronic Cough: How Do Cough Reflex Sensitivity And Subjective Assessments Correlate With Objective Cough Counts During Ambulatory Monitoring? Thorax 2007;62:329-334 2. R Stovold, I.A Forrest., P.A. Corris, D.M. Murphy, J.A. Smith, S Decalmer, G.E. Johnson, J.H. Dark, J.P. Pearson, C Ward. Pepsin, a Biomarker of Aspiration in Lung Allografts: A Putative Association with Rejection. Am. J. Respir. Crit. Care Med. 2007; 175(12): 1298-1303 3. S Decalmer, A. Woodcock, J.A. Smith. Patient mis-reporting may lead to underestimation of cough events. [letter] Chest. 2007 Jul;132(1):358-9 4. S. Decalmer, A. Woodcock, M. Greaves, M. Howe and J.A. Smith. Airway abnormalities at flexible bronchoscopy in patients with chronic cough. Eur.Respir.J 2007; 30(6):1138-42 5. A. Kelsall, S. Decalmer, D. Webster, N. Brown, K. McGuinness, A. Woodcock and J.A.Smith. How to quantify cough? Correlations with quality of life in chronic cough. Eur.Respir.J 2008; 32:1-5 6. A Kelsall, S Decalmer, K McGuinness, A Woodcock, JA Smith. Sex differences and predictors of objective cough frequency in chronic cough. Thorax. 2009; 64(5):393-8. |
| Ethics approval(s) | The South Manchester Research Ethics Committee approved on 15/06/2005 (ref: 05/Q1403/117) |
| Health condition(s) or problem(s) studied | Chronic cough and gastro-oesophageal reflux disease. |
| Intervention | The subject will attend 5 visits, as described below: Visit 1: Lung Function 1.1. Symptom questionnaires (Subjective cough scores, cough quality of life, reflux symptom scores and quality of life) 1.2. History and Physical examination 1.3. Exhaled nitric oxide measurement 1.4. Exhaled breath condensate collection 1.5. Lung Function and exhaled CO testing (<5 ppm to exclude smoking) 1.6. Methacholine Challenge 1.7. Cough challenge test (Single breath, doubling dose method) 1.8. Sputum Induction 1.9. Venepuncture for IgG levels and Tissue Transglutaminase 1.10. 24 hour cough monitoring Visit 2: ENT examination 2.1. Laryngeal appearance scores 2.2. Exclusion of significant nasal disease, laryngeal lesion Visit 3: Bronchoscopy 3.1. Examination of airways and biopsy 3.2. Bronchoalveolar lavage for pepsin/ pepsinogen and differential cell count Visit 4: O.G.D 4.1. Examination of the upper G.I tract for evidence of oesophagitis, Barretts oesophagitis, hiatus hernia and eosinophilic oesophagitis. 4.2. Biopsy of the lower oesophageal mucosa. Visit 5: Oesophageal studies and Cough Monitoring 5.1. Oesophageal Manometry (measure of motility) 5.2. 24hour combined pH and impedance monitoring (pH/MII) 5.3. Simultaneous 24hr objective cough monitoring |
| Intervention type | Other |
| Primary outcome measure(s) | Allocation of patient to one of 3 classifications using results from the above procedures: 1. Negative group (no evidence of reflux disease as determined by oesophageal studies) 2. Distal Reflux acid/non-acid as determined by oesophageal studies 3. Proximal Reflux acid/non-acid as determined by oesophageal studies |
| Key secondary outcome measure(s) | 1. Evidence of aspiration in three groups as determined by study of bronchoscopy samples 2. Evidence of dysmotility in three groups 3. Severity association between cough and reflux events as determined by cough monitoring and questionnaires 4. Comparison of acid and non-acid reflux 5. Comparison of cough rates with and without the oesophageal |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Males and Females over 18 yrs of age 2. Chronic dry cough for more than 8 weeks duration 3. Normal chest x-ray 4. Normal lung function |
| Key exclusion criteria | 1. Upper Respiratory Tract Infection within last 4 weeks 2. Current smokers 3. Pregnancy 4. Opiate medication / ACE Inhibitor use 5. Diabetes Mellitus |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Translational Medicine
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
