Asthma Control in Elderly Patients With Montelukast (ACEM)

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

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

Study Overview

• Status: Completed
• Conditions: Persistent Asthma; Elderly
• Intervention / Treatment: Drug: Monotherapy of medium dose ICS; Drug: Combination of low ICS and montelukast

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 443-721
    • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monotherapy of medium dose ICS	Drug: 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
Experimental: Combination of low ICS and montelukast	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of inflammation	sputum eosinophils and neutrophils	baseline(W1), W5, W9, W13, W17
Time to first well-controlled week		during the 12 weeks of treatment
Sub-group analysis of leukotrienes associated genotypes		visit 1

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: Korea University Guro Hospital; MCM Vaccines B.V.; Hallym University Medical Center; Wonju Severance Christian Hospital
• Investigators: Principal Investigator: Hae-sim Park, MD, PhD, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 10, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: asthma control in elderly patients; age 60-75
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: AJIRB-GEN-CT4-10-095; A070001 (Other Grant/Funding Number: Korea National Enterprise For Clinical Trials)