Asthma Control in Elderly Patients With Montelukast

NCT01147510 | Completed Phase 4

• 2 other identifiers: AJIRB-GEN-CT4-10-095A070001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Asthma; Elderly

Keywords

asthma control in elderly patients; age 60-75

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Biomarkers of inflammation

  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

Study Arms (2)

Monotherapy of medium dose ICS

ACTIVE COMPARATOR

Drug: Monotherapy of medium dose ICS

Combination of low ICS and montelukast

EXPERIMENTAL

Drug: Combination of low ICS and montelukast

Interventions

Combination of low ICS and montelukast DRUG

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.

Combination of low ICS and montelukast

Monotherapy of medium dose ICS DRUG

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

Monotherapy of medium dose ICS

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Hallym University Medical Center: collaborator
• Wonju Severance Christian Hospital: collaborator
• Korea University Guro Hospital: collaborator
• MCM Vaccines B.V.: collaborator

Study Sites (1)

Ajou University Medical Center

Suwon, 443-721, South Korea

Location

MeSH Terms

Interventions

montelukast

Study Officials

• Hae-Sim Park, MD, PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of allergy part, Ajou University School of Medicine

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

KR (1)