N of 1 trials of Montelukast (ML) or Singulair™ in childhood asthma

ISRCTN	ISRCTN69381408
DOI	https://doi.org/10.1186/ISRCTN69381408
Protocol serial number	N0256111271
Sponsor	Department of Health (UK)
Funder	The Royal Free Hampstead NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr David Flynn
Scientific

Department of Child Health
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Phone	+44 (0)20 7794 0500 ext 4124
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	N of 1 trials of Montelukast (ML) or Singulair™ in childhood asthma
Study objectives	Does Montelukast improve asthma in n of 1 placebo trials in paediatric patients whose asthma is controlled by inhaled steroid?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Asthma
Intervention	Montelukast vs placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Montelukast
Primary outcome measure(s)	Service outcomes development
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	09/09/2004

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	30
Key inclusion criteria	30 patients, 12 patients recruited 2001-2002
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	09/09/2001
Date of final enrolment	09/09/2004

Royal Free Hampstead NHS Trust

London
NW3 2QG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan