SINGULAIR (R) as Complementary Therapy to Fixed Associati... | NCT00445107

Studies
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

NCT00445107

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

198Actual

Phase

Phase 3

Conditions

Asthma

Interventions

MK0476, 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
2007_002

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

Nov 1, 2005Actual

Primary Completion Date

May 1, 2006Actual

Completion Date

May 17, 2006Actual

First Submitted Date

Mar 6, 2007

First Submission Date that Met QC Criteria

Mar 6, 2007

First Posted Date

Mar 8, 2007Estimated

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

Description Module

Brief Summary

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of the asthma control questionnaire scores taken over 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

Exclusion Criteria:

Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

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

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