Quality of Life in Asthma and Rhinitis Allergic With Singulair

This study has been completed.

First Received on September 22, 2006. No Changes Posted

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00380705

Purpose

Allow physicians not familiar with anti-leukotriene based therapy to test it

Condition	Intervention	Phase
Asthma Rhinitis Allergic	Drug: MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Quality of Life in Asthma and Rhinitis Allergic With Singulair

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Quality of life measures

Secondary Outcome Measures:

Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis

Estimated Enrollment:	91
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
Voluntary acceptance to participate in the study

Exclusion Criteria:

Patients with cystic fibrosis
Patients with known hypersensitivity to singulair or any of its components
Patients with severe chronic asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380705

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00380705 History of Changes
Other Study ID Numbers:	2006_033
Study First Received:	September 22, 2006
Last Updated:	September 22, 2006
Health Authority:	Ecuador: Public Health Ministry

Additional relevant MeSH terms:

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

Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012