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Completed

NCT Number: NCT01147510

Asthma Control in Elderly Patients With Montelukast

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

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Medical Center

Suwon, 443-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Rate of patients reaching "well controlled asthma status"

    Time frame: 12-weeks treatment

    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 outcomes

  1. Biomarkers of inflammation

    Time frame: baseline(W1), W5, W9, W13, W17

    sputum eosinophils and neutrophils

  2. Time to first well-controlled week

    Time frame: during the 12 weeks of treatment

  3. Sub-group analysis of leukotrienes associated genotypes

    Time frame: visit 1

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Hallym University Medical Center
  • Korea University Guro Hospital
  • MCM Vaccines B.V.
  • Wonju Severance Christian Hospital

Registry information

Official study title

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

Acronym: ACEM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2010
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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