Does montelukast affect the structural proteins in the sputum of patients with asthma?
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN76996992
- Lead Sponsor
- niversity of East Anglia (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Induced sputum mRNA of matrix metalloproteinase (MMP) and tissue inhibitors of MMPs (TIMPs), measured before and after 8 weeks of treatment.
- Secondary Outcome Measures
Name Time Method o secondary outcome measures