Quality of Life in Asthma and Rhinitis Allergic With Sing... | NCT00380705

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

NCT00380705

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

91Estimated

Phase

Phase 4

Conditions

Asthma
Rhinitis Allergic

Interventions

MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_033

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2005Actual

Primary Completion Date

Jul 29, 2005Actual

Completion Date

Jul 29, 2005Actual

First Submitted Date

Sep 22, 2006

First Submission Date that Met QC Criteria

Sep 22, 2006

First Posted Date

Sep 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Estimated

Name	Type	Description	Arm Group Labels	Other Names
MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life measures

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast
D000081206	Duration of Therapy

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided