Asthma Control in Elderly Patients With Montelukast (ACEM)

Ajou University School of Medicine

Status and phase

Completed

Phase 4

Conditions

Persistent Asthma

Elderly

Treatments

Drug: Combination of low ICS and montelukast

Drug: Monotherapy of medium dose ICS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01147510

AJIRB-GEN-CT4-10-095

A070001 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment

140 patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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