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Hull Airway Reflux Questionnaire Scores Following Cough Treatment

This study is currently recruiting participants.
Verified September 2012 by Hull and East Yorkshire Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01515280
First received: January 18, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.


Condition
Cough

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough."

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:
  • Hull Airway Reflux Questionnaire score [ Time Frame: baseline and 2 weeks later ] [ Designated as safety issue: No ]
    The primary objective is to evaluate the effectiveness of HARQ in measuring a clinically significant change in HARQ score from baseline following 14 days treatment.


Secondary Outcome Measures:
  • HARQ SCORES [ Time Frame: baseline and 14 days ] [ Designated as safety issue: No ]
    The Key secondary endpoint will be to evaluate ability of HARQ in demonstrating a clinically significant change in score from baseline in the BC036 arm compared to Placebo arm of main study.


Estimated Enrollment: 244
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic cough
Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients attending chronic cough clinics

Criteria

Inclusion Criteria:

  1. Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
  2. Willing and able to comply with study procedures
  3. Able to provide written informed consent to participate

Exclusion Criteria:

1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515280

Locations
United Kingdom
Hull and East Yorkshire Hospitals Trust Recruiting
Cottingham, East Riding of Yorkshire, United Kingdom, HU16 5JQ
Contact: Caroline e Wright, BScc     441482624067     c.e.wright@hull.ac.uk    
Contact: Alyn H Morice, Professor     441482624067     a.h.morice@hull.ac.uk    
Principal Investigator: Alyn h Morice, Professor            
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Alyn H Morice, MD, Mphil Hull and EastYorkshire 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: NCT01515280     History of Changes
Other Study ID Numbers: 11112011
Study First Received: January 18, 2012
Last Updated: September 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
chronic cough

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013