Study of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough

NCT01656668 | Completed Phase 3

• 1 other identifier: BC1036-001
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to investigate the effect of BC1036 (theobromine) on cough-related quality of life and cough severity following 2 weeks' treatment.

Conditions

Cough

Keywords

Chronic; Acute; Persistent; Longterm; Cough

Outcome Measures

Primary Outcomes (1)

• Leicester Cough Questionnaire (LCQ)

  Cough-related quality of life assessed using the Leicester Cough Questionnaire (LCQ). The baseline-adjusted total LCQ score at Day 14 will be used as the primary endpoint.

  Day 14

Secondary Outcomes (4)

• Adapted 7-day Leicester Cough Questionnaire (LCQ)

  Day 7

• Leicester Cough Questionnaire (LCQ)

  Day 28

• Cough visual analogue scale (VAS)

  From screening to Day 28

• Airway sensitivity using capsaicin challenge

  Day 0 and Day 14

Other Outcomes (1)

• Pulmonary function tests

  From screening to day 28

Study Arms (2)

BC1036

EXPERIMENTAL

BC1036 300 mg capsule capsule by mouth, twice daily, for 14 days.

Drug: BC1036

Sugar Pill

PLACEBO COMPARATOR

Sugar placebo capsule by mouth, twice daily, for 14 days.

Interventions

BC1036 DRUG

Also known as: Theobromine, CAS number 83-67-0, EV Substance code SUB15511MIG

BC1036

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 to 75 years.
• Confirmed diagnosis of a persistent cough.
• Leicester Cough Questionnaire score of ≤ 17 at baseline.
• FEV ≥ 70% of predicted normal, at screening. See protocol Appendix 4 for formula for calculating predicted values.
• Willing to use effective contraception for the duration of the study. Female subjects who are neither surgically sterilized nor post-menopausal (defined as no menses for one year or an FSH value \> 40 mIU/L) will be required to use two methods throughout the study and for 30 days after. Besides abstinence the following contraceptive methods are acceptable: hormonal (e.g. oral, injection, transdermal patch, implant, cervical ring), barrier (e.g. condom or diaphragm with spermicidal agent) or intrauterine device. If hormonal contraceptives are used they must be used from 6 weeks before the first administration of test product. Male subjects must agree to use condoms for the duration of the study and for 30 days after.
• Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures.

You may not qualify if:

• Pregnant or lactating females.
• Major surgery within the 30 days preceding the screening visit.
• Any serious infections within the 30 days prior to the screening visit.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, renal or hepatic disease or psychiatric illness/social situations that would limit compliance with study requirements.
• Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.
• A history of serious adverse allergic reaction to any medication.
• Treatment with another investigational medicinal product within the 30 days prior to enrollment.
• Treatment with:
• Systemic oral steroids within 7 days prior to randomisation at Visit 2.
• Theophylline and theophylline-like agents within 7 days prior to randomisation.
• Opiates or opioids e.g. codeine, dextromethorphan, within 7 days prior to randomisation.
• ACE inhibitors within one month prior to the screening visit.
• Depot injection of corticosteroids within 6 weeks of the screening visit.
• History suggestive of febrile illness within the last 7 days prior to the screening visit.
• Subjects with significant sputum production (defined as more than 5 ml (\~one teaspoon)/day on any three days in the screening period).

Sponsors & Collaborators

• Respicopea Limited: lead

Study Sites (13)

Ormeau Road Health Centre

Belfast, BT7 2EB, United Kingdom

Location

The Queen's University of Belfast

Belfast, United Kingdom

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

The Medical Centre

East Horsely, KT24 6QT, United Kingdom

Location

Sheepcot Medical Centre

Garston, Watford, WD25 0EA, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

Mortimer Surgery

Mortimer, RG7 3SQ, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Ecclesfield Group Practice

Sheffield, S35 9XQ, United Kingdom

Location

Staploe Medical Centre

Soham, Ely, CB7 5JD, United Kingdom

Location

Albany House Medical Centre

Wellingborough, Northampton, NN8 4RW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28839984 DERIVED

MeSH Terms

Conditions

Cough; Bronchiolitis Obliterans Syndrome

Interventions

Theobromine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alyn Morice, BA(Hons) MB.B.Chir MA FRCP

  Castle Hill Hospital

  PRINCIPAL INVESTIGATOR

• Fan Chung, MB, BS, MD, FRCP, DSc (PI)

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Warwick Coulson, BSc, MBBS, DipRCOG, MRCGP

  Albany House Medical Centre

  PRINCIPAL INVESTIGATOR

• Alun George, MA MBBS, DRCOG, DCH, MRCGP

  Staploe Medical Centre

  PRINCIPAL INVESTIGATOR

• Bernard Higgins, MB ChB, MRCP, MD

  Freeman Health System

  PRINCIPAL INVESTIGATOR

• Alan Jackson, MB, BS

  Sheepcot Medical Centre

  PRINCIPAL INVESTIGATOR

• Philip Marazzi, MB, BS

  The Medical Centre

  PRINCIPAL INVESTIGATOR

• Ian Pavord, MB BS, MRCP, FRCP, DM

  Glenfield Hospital

  PRINCIPAL INVESTIGATOR

• Surinder Birring, BSc,MBChB(Hons),MRCP,MD(PI)

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Lorcan McGarvey, MBBCh,BAOHons,MRCP,MD,CCST(PI)

  The Queen's University of Belfast

  PRINCIPAL INVESTIGATOR

• Richard Oliver, MB ChB, MRCGP

  Ecclesfield Group Practice

  PRINCIPAL INVESTIGATOR

• Chris Strang, MB BS, D. Obst, RCOG M

  Mortimer Surgery

  PRINCIPAL INVESTIGATOR

• Damien McNally, MB,BCh,BAO,DRCOG,DMH,MRCGP

  Ormeau Road Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 3, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

GB (13)