PARENT-DETERMINED ORAL MONTELUKAST THERAPY FOR PRESCHOOL WHEEZE (Wheeze And Intermittent Treatment: WAIT) Study Protocol Version 7 Signed by Professor Jonathan Grigg Chief Investigator th Dated: 24 June 2011 WAIT Trial_ Protocol_v7_24th June 2011 Page 1 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Full title of the protocol: Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype. Short title (Acronym): Wheeze And Intermittent Treatment: WAIT MREC Reference Number: 09/H1102/110 – 23rd November 2009 MHRA Reference Number: 21313/0024/01-0001 – 7th January 2010 EudraCT Number: 2009-015626-11 ClinicalTrials.gov: NCT01142505 NIHR CSP Number: 35170 Sponsor: Queen Mary University London Approval Ref 006539 QM Representative of the sponsor: Mr Gerry Leonard (Joint Research Office) 5 Walden Street Whitechapel, London, E1 2EF Phone: 0207 882 7260 Email: [email protected] Funder: National Institute of Health Research/ Medical Research Council Efficacy and Mechanism Evaluation Programme Alpha House, University of Southampton, Science Park, Southampton, SO16 7NS, Tel: 02380594303 Fax: 02380595939 Post Award Manager: Dr Jane Sinclair EME Programme Manager [email protected] All Trusts and organisations: Barts and The London School of Medicine and Dentistry Centre for Paediatrics Institute of Cell and Molecular Science The Blizard Building 4 Newark Street, London E1 2AT, UK Centre for Health Sciences WAIT Trial_ Protocol_v7_24th June 2011 Page 2 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Institute of Health Sciences Education 2 Newark Street, London E1 2AT, UK Pragmatic Clinical Trials Unit 2 Newark St, London E1 2AT, UK Barts and The London NHS Trust Royal London Hospital Whitechapel Road London E1 1BB, UK University Hospitals of Leicester NHS Trust UHL Children’s Hospital Leicester Royal Infirmary, Infirmary Square, Leicester LE1 5WW University of Aberdeen Centre of Academic Primary Care Foresterhill Health Centre Westburn Road Aberdeen AB25 2AY NHS Grampian Royal Aberdeen Children's Hospital Department of Child Health University of Aberdeen Foresterhill Aberdeen AB25 2ZG Tel 01224-552471 Fax 01224-551919 (See Appendix A for later added sites) Pharmacies: Jeanette Hansen Clinical trials co-ordinator Pharmacy Department Royal London Hospital London E1 1BB [email protected] Judith Bwire Pharmacy Department UHL Children’s Hospital Leicester Royal Infirmary, Infirmary Square, Leicester LE1 5WW WAIT Trial_ Protocol_v7_24th June 2011 Page 3 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 [email protected] Julia Subedi Pharmacy Department NHS Grampian Royal Aberdeen Children's Hospital University of Aberdeen Foresterhill Aberdeen AB25 2ZG [email protected] Laboratories: Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, The Blizard Building, 4 Newark Street, Whitechapel, London E1 2AT, UK Jagiellonian University Medical School Division of Molecular Biology 8 Skawinska Str. Krakow 31-066 Poland Courier: City Link Ltd Riverbank, Meadows Business Park Blackwater, Surrey GU17 9AB, UK IMP Supplier: Nova Laboratories Ltd Martin House Gloucester Crescent Wigston Leicester LE18 4YL WAIT Trial_ Protocol_v7_24th June 2011 Page 4 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Chief and Principal Investigator: Professor Jonathan Grigg* Centre for Paediatrics Institute of Cell and Molecular Science The Blizard Building 4 Newark Street, London E1 2AT, UK Tel 02078822206 Mobile 07787550774 Fax 02078825555 Email [email protected] Clinical Co- Principal Investigators *member of Trial Steering Group: Prof Christopher Griffiths* Professor of Primary Care Centre for Health Sciences Barts and The London School of Medicine and Dentistry 2 Newark St, London E1 2AT Tel 0207 882 2503 Fax 0207 882 2552 Email [email protected] Professor David Price* Professor of Primary Care Centre of Academic Primary Care University of Aberdeen Foresterhill Health Centre Westburn Road Aberdeen AB25 2AY Tel : 01224 553066 Fax : 01224 550683 [email protected] Also for Professor David Price Comprehensive Local Research Network Co-director Norfolk & Suffolk CLRN, Research and Development Office, Room 32 (Medical School), Level 3, East Block, Norfolk & Norwich University Hospital, Norwich, NR4 7UY Dr Stephen Turner* Senior Lecturer in Paediatric Respiratory Medicine Department of Child Health Royal Aberdeen Children's Hospital University of Aberdeen Foresterhill Aberdeen AB25 2ZG WAIT Trial_ Protocol_v7_24th June 2011 Page 5 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Tel; 01224-552471 Fax 01224-551919 [email protected] Dr Hitesh Pandya* Senior Lecturer in Child Health Division of Infection Immunity and Inflammation University Hospitals of Leicester NHS Trust Children’s Hospital University of Leicester Robert Kilpatrick Clinical Sciences Building Leicester Royal Infirmary Leicester, LE2 7LX, UK Tel 01162525810 Fax 01162522958 [email protected] Local Collaborator (Tower Hamlets PCT): Vanessa Lodge NHS Tower Hamlets Aneurin Bevan House 81 Commercial Road London E1 1RD Telephone: 020 7092 5598 Fax no: 02070925114 Email: [email protected] Project Manager: Professor Jonathan Grigg Professor of Paediatric Respiratory Medicine, Honorary Consultant, Centre for Paediatrics Institute of Cell and Molecular Science Blizard Building 4 Newark Street, London E1 2AT, UK Tel 02078822206 Mobile 07787550774 Fax 02078825555 Email [email protected] Clinical Research Fellow: Dr Chinedu Nwokoro* Centre for Paediatrics Institute of Cell and Molecular Science Blizard Building 4 Newark Street, London E1 2AT, UK Tel 0207882280 Fax 02078822195 WAIT Trial_ Protocol_v7_24th June 2011 Page 6 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Email [email protected] Trial Co-ordinator: Suzi Miranbeg Trial Co-ordinator Centre for Paediatrics 4 Newark St London E1 2AT Tel: 0207 882 2619 Fax: 0207 882 2195 Email: [email protected] Trial Monitoring: Barts and the London Joint Research Office 24-26 Walden Street Whitechapel, London, E1 2AN Phone: 0207 882 7260 Email: [email protected] Study Statistician: Professor Sandra Eldridge*/Clare Rutterford Professor of Biostatistics Centre for Health Sciences Barts and the London School of Medicine and Dentistry 2 Newark St, London E1 2AT Tel 0207 882 2519 Fax 0207 882 2552 Email [email protected], [email protected] Independent Members of Trial Steering Group Chair Professor Warren Lenney Consultant Respiratory Paediatrician Associate Medical Director, North Staffordshire NHS Research & Development Institute for Science & Technology in Medicine, Keele University, Thornburrow Drive, Hartshill Stoke-on-Trent, ST4 7QB Tel 01782 552667 E mail [email protected] Dr Jay Panickar Consultant Respiratory Physician WAIT Trial_ Protocol_v7_24th June 2011 Page 7 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Royal Manchester Children's Hospital Oxford Road Manchester M13 9WL E mail [email protected] Dr Edward Simmonds Consultant Paediatrician Walsgrave General Hospital Clifford Bridge Road Coventry CV2 2DX Tel 02476675746 E mail [email protected] Data Monitoring Committee members: Chair Professor Andrew Bush Professor of Paediatric Respirology, Imperial College, Honorary Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK. Tel 020 7352 8121 x2255 E mail [email protected] Dr Paul Lambert Reader in Medical Statistics Centre for Biostatistics & Genetic Epidemiology Department of Health Sciences University of Leicester 2nd Floor, Adrian Building University Road Leicester LE1 7RH Tel: 0116 229 7265 Fax: 0116 229 7250 e-mail: [email protected] Mr Ian Jarrold Research Manager British Lung Foundation, 73-75 Goswell Road, London EC1V 7ER Tel: 0858050520 E mail [email protected] Other Study Contacts: Professor Clive Seale WAIT Trial_ Protocol_v7_24th June 2011 Page 8 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Professor of Medical Sociology Centre for Health Sciences Barts and The London School of Medicine and Dentistry 2 Newark St, London E1 2AT Tel 0207 882 2503 Fax 0207 882 2552 Email [email protected] Professor Robert Walton Professor of Primary Medical Care Centre for Health Sciences Barts and The London School of Medicine and Dentistry Abernethy Building 2 Newark Street Whitechapel London E1 2AT Phone: 020 7882 2502 Fax: 020 7882 2552 [email protected] Dr Thomas J Vulliamy Senior Lecturer Molecular Biology Centre for Paediatrics Institute of Cell and Molecular Science The Blizard Building 4 Newark Street, London E1 2AT, UK Tel 02078822623 Fax 020278822195 [email protected] Ms Michelle Moore* Parent Representation Co-ordinator UHL Children’s Hospital University of Leicester Robert Kilpatrick Clinical Sciences Building Leicester Royal Infirmary Leicester, LE2 7LX, UK Tel 01162525810 Fax 01162522958 [email protected] Dr John Holloway University of Southampton