Clinical trial NCT01147510: Asthma Control in Elderly Patients With Montelukast
Official title: A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Persistent Asthma
Elderly
Keywords: asthma control in elderly patients
age 60-75
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
name: Wonju Severance Christian Hospital
name: Korea University Guro Hospital
name: MCM Vaccines B.V.
First posted: 2010-06-22
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients reaching "well controlled asthma status"
timeFrame: 12-weeks treatment
Secondary outcomes:
measure: Biomarkers of inflammation
timeFrame: baseline(W1), W5, W9, W13, W17
measure: Time to first well-controlled week
timeFrame: during the 12 weeks of treatment
measure: Sub-group analysis of leukotrienes associated genotypes
timeFrame: visit 1
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: Ajou University School of Medicine
name: Hae-Sim Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: