To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

Asthma Clinical Trial

Official title:

An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398151
• Other study ID #: 0476-366
• Secondary ID: 2006_043
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2005
• Est. completion date: January 18, 2006

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 18, 2006
• Est. primary completion date: January 18, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival

• Male or female outpatient 20 years of age and older

• Patients with the following signs and symptoms of asthma and allergic rhinitis:

history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

• Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug

• Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis

• Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study

• Treated with montelukast within 3 months before enrollment

• Unable to perform acceptable, reproducible spirometry and peak flow measurement

• Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

Related Conditions & MeSH terms

• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment: 12 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
Secondary	Asthma symptoms score throughout the study