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Bronchial Hyper-Responsiveness in Reflux Cough

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Hull and East Yorkshire Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00668317
First received: April 24, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 24, 2008
April 24, 2008
September 2006
December 2008   (final data collection date for primary outcome measure)
Reduction in methacholine sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
nprovement in cough symptoms measured using Leicester cough questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
 
 
 
Bronchial Hyper-Responsiveness in Reflux Cough
An 8 Week Non-Selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-Responsiveness

The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.
 
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Reflux Cough
Drug: Losec and Zantac
Anti-reflux medications
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive methacholine challenge test PC20 less than 4mg/ml (Can be previously documented in patients notes within last 4weeks)
  • Written informed consent
  • Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-oesophageal reflux
  • Male and female subjects of at least 18 yrs of age
  • Subjects able to perform satisfactory FEV1 manoeuvres
  • Subjects able to understand the study and co-operate with the study procedures
  • Subjects who consent to their general practitioner (GP) being informed of their study participation

Exclusion Criteria:

  • has had a heart attack in the last three months
  • suffers from angina, hypertension or ischaemic heart disease
  • has epilepsy for which he/she is taking medication
  • FEV1< 60% predicted
  • FEV1<1.6L
  • Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
  • Suffering from any concomitant disease which may interfere with study procedures or evaluation.
  • A lower respiratory tract infection 4 weeks prior to entry on to study
  • Participation in another study (use of investigational product) within 30 days preceding entry on to study.
  • Alcohol or drug abuse
  • Use of opiates to treat cough 1 week prior to enrollment
  • Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
  • Subjects who have significant pathology on most recent chest X-Ray.
  • Inability to understand the procedures and the implications of a challenge test
  • Patients already taking or have taken in last 4 weeks PPI and H2 receptor antagonist (full acid suppression treatment
Both
18 Years to 75 Years
No
Contact: Hazel Brook 44-014-8262-4067 h.brook@hull.ac.uk
United Kingdom
 
NCT00668317
2006-004102-13
Yes
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
Hull and East Yorkshire Hospitals NHS Trust
 
 
Hull and East Yorkshire Hospitals NHS Trust
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP