Effect of Add-on Montelukast to Inhaled Corticosteroids o... | NCT00913328

Studies
Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

NCT00913328

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jun 4, 2009Estimated

Enrollment

31Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Montelukast (Singulair)
Placebo

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

Status Module

Record Verification Date

Jun 2009

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

Aug 2002

Primary Completion Date

May 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 2009Estimated

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

Jun 3, 2009

Last Update Posted Date

Jun 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast	Active Comparator	Oral montelukast 10 mg once daily for 12 weeks	Drug: Montelukast (Singulair)
Placebo	Placebo Comparator	Oral placebo once daily for 12 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast (Singulair)	Drug	10 mg tablet once daily	Montelukast	Singulair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline in maximal FEV1 decline at the dose-response plateau		After 12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in PD20 methacholine		After 12 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-smoking adults with mild to moderate persistent asthma:
- FEV1 > 70 % pred
- PD20 methacholine < 3.9 mmol
- treated for at least 3 months with a stable dose of inhaled corticosteroids
Documented dose-response plateau to inhaled methacholine on two occasions
Males and non-pregnant females

Exclusion Criteria:

Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
Viral respiratory tract infections within the 3 weeks prior to enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zuzana Diamant, MD, PhD	Erasmus Medical Center	Principal Investigator
Charlotte S Ulrik, MD, DMSc	Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark	Principal Investigator

Locations

Not provided

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

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided