Does montelukast affect the structural proteins in the sputum of patients with asthma?

ISRCTN	ISRCTN76996992
DOI	https://doi.org/10.1186/ISRCTN76996992
Secondary identifying numbers	6

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 Andrew Wilson
Scientific

Biomedicine Group
School of Medicine, Health Policy and Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Study design	Single centre open labelled pilot study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of montelukast therapy on messenger ribonucleic acid (mRNA) profile of matrix metalloproteinases and their inhibitors in the sputum of patients with asthma
Study objectives	The expression profile of matrix metalloproteinases and their inhibitors is modified by treatment with montelukast.
Ethics approval(s)	Norfolk Research Ethics Committee (REC) approved on the 14th April 2009 (ref: 09/H0310/29)
Health condition(s) or problem(s) studied	Asthma
Intervention	Oral montelukast 10 mg once daily for 8 weeks is given to all patients. Follow-up at 8 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Montelukast
Primary outcome measure	Induced sputum mRNA of matrix metalloproteinase (MMP) and tissue inhibitors of MMPs (TIMPs), measured before and after 8 weeks of treatment.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/03/2009
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	10
Key inclusion criteria	1. Male or female, aged 18 to 60 years 2. Diagnosed with asthma, defined as episodic chest tightness, wheezing and dyspnoea, cough 3. Non-smoker or ex-smoker for at least 10 years and a smoking history of less than 5 pack years 4. History of asthma symptoms for more than 10 years 5. Receiving as required short acting bronchodilators 6. Post-bronchodilator forced expiratory volume in one second (FEV1) 50 - 100% predicted 7. Evidence of airway calibre reversibility within the previous 12 months: reversibility to salbutamol of 12% following 400 µg inhaled salbutamol, histamine PC20 less than 8 mg/ml, diurnal variation in peak expiratory flow of 20% 8. Able to produce sputum after induction with saline
Key exclusion criteria	1. Cardiac or pulmonary disease other than asthma 2. Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study 3. Receiving inhaled or oral corticosteroid therapy, long acting Ò2 agonist therapy or leukotriene modifying therapy for the previous 1 month 4. Severe or uncontrolled co-morbid disease 5. Pregnancy or breastfeeding 6. Unable to give written informed consent
Date of first enrolment	01/03/2009
Date of final enrolment	01/09/2009

Biomedicine Group

Norwich
NR4 7TJ
United Kingdom

University of East Anglia (UK)
University/education

Research, Enterprise & Engagement Office
The Registry
Norwich
NR4 7TJ
England
United Kingdom

Website	http://www.uea.ac.uk/
"ROR"	https://ror.org/026k5mg93

Industry

Merck Sharp & Dohme Ltd (MSD) (UK)

No information available

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

24/05/2016: No publications found, verifying study status with principal investigator