Asthma Control in Elderly Patients With Montelukast

Overview[ - collapse ][ - ]

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
ConditionPersistent Asthma
Elderly
InterventionDrug: Combination of low ICS and montelukast
Drug: Monotherapy of medium dose ICS
PhasePhase 4
SponsorAjou University School of Medicine
Responsible PartyAjou University School of Medicine
ClinicalTrials.gov IdentifierNCT01147510
First ReceivedJune 18, 2010
Last UpdatedNovember 10, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 18, 2010
Last Updated DateNovember 10, 2013
Start DateJuly 2010
Estimated Primary Completion DateSeptember 2012
Current Primary Outcome MeasuresRate 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)
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleAsthma Control in Elderly Patients With Montelukast
Official TitleA Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Persistent Asthma
  • Elderly
InterventionDrug: 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.
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
Study Arm (s)
  • Active Comparator: Monotherapy of medium dose ICS
  • Experimental: Combination of low ICS and montelukast

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment140
Estimated Completion DateSeptember 2012
Estimated Primary Completion DateSeptember 2012
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
GenderBoth
Ages60 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01147510
Other Study ID NumbersAJIRB-GEN-CT4-10-095
Has Data Monitoring CommitteeNo
Information Provided ByAjou University School of Medicine
Study SponsorAjou University School of Medicine
CollaboratorsHallym 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
Verification DateNovember 2013

Locations[ + expand ][ + ]

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