Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2005TM011 (R&D)
Study information
Scientific title
A study to accurately define gastro-oesophageal reflux disease in patients with chronic cough: An observational, cross-sectional cohort study
Acronym
SD/AK GORD
Study hypothesis
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
The South Manchester Research Ethics Committee approved on 15/06/2005 (ref: 05/Q1403/117)
Study design
Single centre observational cross sectional cohort study running over 3 years.
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/07/2005
Overall trial end date
31/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
31/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Translational Medicine
Manchester
M23 9LT
United Kingdom
Funders
Funder type
Charity
Funder name
Moulton Charitable Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20864619
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22797535
Publication citations
-
Results
Kelsall A, Houghton LA, Jones H, Decalmer S, McGuinness K, Smith JA, A novel approach to studying the relationship between subjective and objective measures of cough., Chest, 2011, 139, 3, 569-575, doi: 10.1378/chest.10-0438.
-
Results
Decalmer S, Stovold R, Houghton LA, Pearson J, Ward C, Kelsall A, Jones H, McGuinness K, Woodcock A, Smith JA, Chronic cough: relationship between microaspiration, gastroesophageal reflux, and cough frequency., Chest, 2012, 142, 4, 958-964, doi: 10.1378/chest.12-0044.