Asthma Control in Elderly Patients With Montelukast

Elderly Clinical Trial

— ACEM  

Official title:

A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147510
• Other study ID #: AJIRB-GEN-CT4-10-095
• Secondary ID: A070001
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2010
• Last updated: November 10, 2013
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 60 - 75 years

• Patients diagnosed with asthma (NIH, 2007) over six months ago

• Patients maintaining monotherapy of low dose inhaled budesonide (pulmicort 400µg/day or ciclesonide 160 µg/day or fluticasone 250 µg/day) or combination of low dose inhaled budesonide and LABA (Seretide® 250 µg/day or Symbicort® 320 µg/day ) for over a month before the participation in this trial

• Patients not reaching 'well controlled asthma status' with four-week monotherapy of low dose inhaled budesonide (Pulmicort 400 µg/day)

• Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial

Exclusion Criteria:

• Patients who show a symptom of an acute disease within 28 days before the beginning of this trial (administration of trial medication)

• Volunteers who are found to be unsuitable through screening tests

• Patients with history of hypersensitivity to montelukast or budesonide

• Patients participating in other clinical trial within three months before the beginning of this trial (administration of trial medication)

• current smokers having more than 10PYs of smoking history

• Patients needing administration of a medication which can affect asthma control such as systemic and immunoregulatory drugs (cyclosporin, omalizumab, etc.) due to a disease except asthma

Related Conditions & MeSH terms

• Asthma
• Elderly
• Persistent Asthma

Intervention

Drug:
• Combination of low ICS and montelukast
Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.
• Monotherapy of medium dose ICS
Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (5)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Hallym University Medical Center, Korea University Guro Hospital, MCM Vaccines B.V., Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients reaching "well controlled asthma status"	Rate of patients reaching "well controlled asthma status" after 12-week treatment : evaluating comprehensively frequency of day symptoms and night symptoms, limit of activities and use of rescue medicine based on GINA guideline for asthma management (GINA 2006) and PEF or FEV1(% predicted)	12-weeks treatment
Secondary	Biomarkers of inflammation	sputum eosinophils and neutrophils	baseline(W1), W5, W9, W13, W17
Secondary	Time to first well-controlled week		during the 12 weeks of treatment
Secondary	Sub-group analysis of leukotrienes associated genotypes		visit 1