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

The effect of montelukast therapy on messenger ribonucleic acid (mRNA) profile of matrix metalloproteinases and their inhibitors in the sputum of patients with asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76996992
Enrollment
10
Registered
2009-06-17
Start date
2009-03-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

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

Sponsors

University of East Anglia (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Induced sputum mRNA of matrix metalloproteinase (MMP) and tissue inhibitors of MMPs (TIMPs), measured before and after 8 weeks of treatment.

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026