RADAR: SingulaiR® in Asthma anD Allergic Rhinitis An 8 week multicenter, open-label, observational study to evaluate the effectiveness of adding Montelukast Sodium (SINGULAIR®) 10 mg per day to inhaled corticosteroid or to inhaled corticosteroid/long-acting beta 2-agonist therapy in adult subjects with asthma and allergic rhinitis. - RADAR: SingulaiR® in Asthma anD Allergic Rhinitis

Merck Frosst Canada Ltd.0 个研究点目标入组 1,350 人开始时间: 2015年4月8日最近更新: 2015年7月10日

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•Patients are 2> 15 years old (in the Province of Quebec, patients are 2: >18 years-old).
•Patient is diagnosed with asthma for at least 6 months.
•Patient has signed the Informed Consent before completing the survey.
•Patient is diagnosed with asthma for at least 6 months
•Patient is diagnosed with allergic rhinitis for at least one year.
•Patient's forced ,expiratory volume in one second (FEV1) or Peak expiratory flow is > 80% of predicted value on the day of visit 1.
•Patient is uncontrolled as per Canadian Asthma Consensus Guidelines.
•Patient is a user of ICS or ICS/LABA at any dosage. The dosage of ICS or ICS/LABA must have been stable for the past 30 days. A maximum of 4 patients on ICS/LABA per block of 8 will be allowed in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 13
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Patient is well controlled with current controller therapy.
•Patient is already on montelukast sodium.
•Patient has rhinitis medicamentosa or non allergic rhinitis.
•Patient has evidence of significant nasal obstruction due to structural causes (e.g. markedly deviated nasal septum) that significantly interferes with nasal airflow as determined by the investigator.
•Patient is on a long-acting beta 2-agonist (LABA) alone, i.e. formoterol (Oxeze), salmeterol (Serevent).
•Patient is currently using an antibiotic for respiratory tract infection or has been treated with an antibiotic within 30 days of Visit 1 for respiratory tract infection (Initiation of antibiotic treatment will be allowed during the study).
•Patient has a history of Chronic Obstructive Pulmonary Disease (COPD).
•Patient has a history of cystic fibrosis, immune deficiency requiring specific therapy or any other diseases that could influence the evolution of asthma.
•Patient with hypersensitivity to any component of montelukast sodium 10 mg tablets.
•Patient has participated in an investigational drug trial in the last 30 days (prior to Visit 1).

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