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Trial record 47 of 1348 for:    cough

Hull Airway Reflux Questionnaire Scores Following Cough Treatment

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ClinicalTrials.gov Identifier: NCT01515280
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust

Brief Summary:
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 Theobromine 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 or disease
Cough

Study Type : Observational
Actual Enrollment : 57 participants
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 Theobromine in the Management of Cough."
Study Start Date : January 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Group/Cohort
Chronic cough
Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm



Primary Outcome Measures :
  1. Hull Airway Reflux Questionnaire score [ Time Frame: baseline and 2 weeks later ]
    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 :
  1. HARQ SCORES [ Time Frame: baseline and 14 days ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515280


Locations
United Kingdom
Hull and East Yorkshire Hospitals Trust
Cottingham, East Riding of Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Alyn H Morice, MD, Mphil Hull and EastYorkshire NHS Trust

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
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Prof A H Morice, 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