Bronchial Hyper-responsiveness in Reflux Cough

NCT00668317 | Terminated Phase 3 Results DMC

• 1 other identifier: 2006-004102-13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cough

Keywords

Hyper-responsiveness, reflux cough

Outcome Measures

Primary Outcomes (1)

• Change in Methacholine Sensitivity

  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

  baseline and 8 weeks

Secondary Outcomes (1)

• Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire

  8 weeks

Study Arms (1)

omeprazole and ranitidine

OTHER

20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Drug: Omeprazole; Drug: Ranitidine

Interventions

Omeprazole DRUG

20 mg BD tablet 8 weeks duration

Also known as: Losec

omeprazole and ranitidine

Ranitidine DRUG

300 mg od nocte tablet 8weeks duration

Also known as: Zantac

omeprazole and ranitidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (1)

• Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. doi: 10.1046/j.0306-5251.2001.01475.x. No abstract available.

  PMID: 11678780 BACKGROUND

Related Links

• Publication Link

MeSH Terms

Conditions

Cough

Interventions

Omeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Results Point of Contact

• Title: Clinical trials Manager
• Organization: Hull and East Yorkshire Hospitals Trust

c.e.wright@hull.ac.uk

01482 624067

Study Officials

• Alyn H Morice, Professor

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: July 23, 2019
• Results First Posted: November 16, 2012

Record last verified: 2019-07

Locations

GB (1)