Hull Airway Reflux Questionnaire Scores Following Cough Treatment

NCT ID: NCT01515280

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cough

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic cough

Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyn H Morice, MD, Mphil

Role: PRINCIPAL_INVESTIGATOR

Hull and EastYorkshire NHS Trust

Locations

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Hull and East Yorkshire Hospitals Trust

Cottingham, East Riding Of Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.

Reference Type RESULT
PMID: 28839984 (View on PubMed)

Related Links

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Other Identifiers

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11112011

Identifier Type: -

Identifier Source: org_study_id

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