Condition category
Respiratory
Date applied
09/12/2008
Date assigned
17/06/2009
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Wilson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6

Study information

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

Acronym

Study hypothesis

The expression profile of matrix metalloproteinases and their inhibitors is modified by treatment with montelukast.

Ethics approval

Norfolk Research Ethics Committee (REC) approved on the 14th April 2009 (ref: 09/H0310/29)

Study design

Single centre open labelled pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

Oral montelukast 10 mg once daily for 8 weeks is given to all patients. Follow-up at 8 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Montelukast

Primary outcome measures

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 trial start date

01/03/2009

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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 ƒÒ2 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

Recruitment start date

01/03/2009

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Biomedicine Group
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Industry

Funder name

Merck Sharp & Dohme Ltd (MSD) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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