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Bronchial Hyper-responsiveness in Reflux Cough

This study has been terminated.
(Primary care physicians began prescribing antacid therapy for chronic cough)
Sponsor:
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00668317
First received: April 24, 2008
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cough
 Drug: Omeprazole
Drug: Ranitidine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness

Resource links provided by NLM:

MedlinePlus related topics: Cough GERD
U.S. FDA Resources

Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • Change in Methacholine Sensitivity [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]

    Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).

    To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine



Secondary Outcome Measures:
  • Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omeprazole and ranitidine
20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
 Drug: Omeprazole
20 mg BD tablet 8 weeks duration
Other Name: Losec
Drug: Ranitidine
300 mg od nocte tablet 8weeks duration
Other Name: Zantac

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668317

Locations
United Kingdom
Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Alyn H Morice, Professor Hull and East Yorkshire Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Prof A H Morice, Professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00668317     History of Changes
Other Study ID Numbers: 2006-004102-13
Study First Received: April 24, 2008
Results First Received: March 16, 2012
Last Updated: October 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
Hyper-responsiveness, reflux cough

Additional relevant MeSH terms:
Cough
Bronchial Hyperreactivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Omeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013