Condition category
Signs and Symptoms
Date applied
23/08/2010
Date assigned
13/09/2010
Last edited
11/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jaclyn Ann Smith

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

University Hospital of South Manchester (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes