A study to accurately define reflux in patients with chronic cough

ISRCTN ISRCTN62337037
DOI https://doi.org/10.1186/ISRCTN62337037
Secondary identifying numbers 2005TM011 (R&D)
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

School of Translational Medicine
University Hospital of South Manchester
2nd Floor, Education & Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Study information

Study designSingle centre observational cross sectional cohort study running over 3 years.
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA study to accurately define gastro-oesophageal reflux disease in patients with chronic cough: An observational, cross-sectional cohort study
Study acronymSD/AK GORD
Study objectivesWe 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) studiedChronic cough and gastro-oesophageal reflux disease.
InterventionThe 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 typeOther
Primary outcome measureAllocation 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 measures1. 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 study start date01/07/2005
Completion date31/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2005
Date of final enrolment31/07/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Translational Medicine
Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester (UK)
Hospital/treatment centre

c/o Dr. Andrew Maines
Head of Research & Development
Education & Research Centre
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Charity

Moulton Charitable Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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