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Completed

NCT Number: NCT00545844

Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.

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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

15 year and older

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 a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
  • Peak expiratory flow is > or = 80% of predicted value on the day of visit 1
  • Uncontrolled as per Canadian asthma consensus guidelines

Exclusion criteria

  • Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
  • Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Treatment and study plan

montelukast sodium

Drug

montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment

Other names: Singulair

Primary outcomes

  1. Asthma Control

    Time frame: 8 weeks (from Week 0 to Week 8)

    Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters.

Secondary outcomes

  1. The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score

    Time frame: 8 weeks (from Week 0 to Week 8)

    Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score

  2. Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)

    Time frame: 8 weeks (from Week 0 to Week 8)

    The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.

Other outcomes

  1. Patient Global Satisfaction

    Time frame: 8 weeks (from Week 0 to Week 8)

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

  2. Physician Global Satisfaction

    Time frame: 8 weeks (from Week 0 to Week 8)

    At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.

  3. Patient Global Allergic Rhinitis Symptoms Assessment

    Time frame: 8 weeks (from Week 0 to Week 8)

    At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2007
Registry last updated
May 23, 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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