Asthma Control in Elderly Patients With Montelukast (ACEM)

This study has been completed.
Sponsor:
Collaborators:
Hallym University Medical Center
Wonju Severance Christian Hospital
Korea University Guro Hospital
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01147510
First received: June 18, 2010
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Persistent Asthma
Elderly
Drug: Combination of low ICS and montelukast
Drug: Monotherapy of medium dose ICS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • Rate of patients reaching "well controlled asthma status" [ Time Frame: 12-weeks treatment ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Biomarkers of inflammation [ Time Frame: baseline(W1), W5, W9, W13, W17 ] [ Designated as safety issue: No ]
    sputum eosinophils and neutrophils

  • Time to first well-controlled week [ Time Frame: during the 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Sub-group analysis of leukotrienes associated genotypes [ Time Frame: visit 1 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: July 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147510

Locations
Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Hallym University Medical Center
Wonju Severance Christian Hospital
Korea University Guro Hospital
Sanofi Pasteur MSD
Investigators
Principal Investigator: Hae-Sim Park, MD, PhD Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: Hae-Sim Park, Professor, Department of allergy part, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01147510     History of Changes
Other Study ID Numbers: AJIRB-GEN-CT4-10-095, A070001
Study First Received: June 18, 2010
Last Updated: November 10, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Ajou University School of Medicine:
asthma control in elderly patients
age 60-75

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014