N of 1 trials of Montelukast (ML) or Singulair™ in childhood asthma
| ISRCTN | ISRCTN69381408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69381408 |
| Secondary identifying numbers | N0256111271 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Dr David Flynn
Scientific
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 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Montelukast |
| Primary outcome measure | Service outcomes development |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 09/09/2001 |
| Completion date | 09/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The Royal Free Hampstead NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
