Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast

Launched by UNIVERSITY OF EAST ANGLIA · Jul 27, 2009

Keywords

ClinConnect Summary

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:

* Clinical examination
* Spirometry
* Induced sputum
* Diary Card

Spirometry:

This will be performed with a Microlab spirometer (Micro Medical Ltd, Rochester, Kent, UK). The procedure will be according to American Thoracic Society specifications(13).

Diary Card Data:

Patients will record their symptoms on a daily basis in the morning according to "cough", "breathlessness" and "wheeze" on a...

Gender

ALL

Eligibility criteria

• 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