Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)

January 31, 2022 updated by: Organon and Co

Quality of Life in Asthma and Rhinitis Allergic With Singulair

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

91

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life measures

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2005

Primary Completion (Actual)

July 29, 2005

Study Completion (Actual)

July 29, 2005

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-365
  • 2006_033

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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