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Completed

NCT Number: NCT00832455

Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient Is Diagnosed With Asthma For At Least 6 Months
  • Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
  • Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
  • Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion criteria

  • As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
  • Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

Treatment and study plan

montelukast sodium

Drug

Montelukast 4-5 mg for 12 weeks, oral tablet

Other names: Singular

Primary outcomes

  1. Asthma Control Questionnaire (ACQ)

    Time frame: Week 0, 4, and 12

    ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.

Secondary outcomes

  1. Asthma Control Questionnaire (ACQ)

    Time frame: Week 0, 4, and 12

    ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.

Other outcomes

  1. Physician Global Satisfaction

    Time frame: week 0, 4, 8 and 12

    At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.

  2. Patient Global Satisfaction

    Time frame: Week 0, 4, 8 and 12

    At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.

  3. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

    Time frame: Weeks 4, 8, and 12

    The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ).

    PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 30, 2009
Registry last updated
May 13, 2024

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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