Status:
COMPLETED
Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ...
Detailed Description
The following measurements will be performed at screening: * Informed consent * Clinical examination * Spirometry * Induced sputum The following will be performed after 8 weeks of study medication: ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female, aged 18 to 60 years.
- Diagnosed with asthma, defined as episodic chest tightness, wheezing and dyspnoea, cough.
- Non-Smoker or Ex-Smoker for at least 10 years and a smoking history of less than 5 pack years.
- History of asthma symptoms for more than 10years.
- Receiving as required short acting bronchodilators.
- Post bronchodilator FEV1 50 to 100 % predicted
- Evidence of airway calibre reversibility within the previous 12 months: reversibility to salbutamol of 12% following 400mcg inhaled salbutamol, histamine PC20 \< 8mg/ml, diurnal variation in peak expiratory flow of 20%.
- Able to produce sputum after induction with saline.
- Exclusion criteria:
- Cardiac or pulmonary disease other than asthma.
- Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.
- Receiving inhaled or oral corticosteroid therapy, long acting Beta2 agonist therapy or leukotriene modifying therapy for the previous 1 month.
- Severe or uncontrolled co-morbid disease.
- Pregnancy or breastfeeding.
- Unable to give written informed consent
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00947453
Start Date
July 1 2009
End Date
December 1 2011
Last Update
August 23 2012
Active Locations (1)
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1
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ