Optimization of Asthma Treatment Through Exhaled NO for I... | NCT00421018

Studies
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)

NCT00421018

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Aug 15, 2012Estimated

Enrollment

187Actual

Phase

Not Applicable

Conditions

Allergic Asthma

Interventions

Single corticosteroid inhalers and Singulair

Countries

Sweden

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

Aug 2012

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 2006

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 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 14, 2012

Last Update Posted Date

Aug 15, 2012Estimated

Name	Class
Region Stockholm	OTHER_GOV
Aerocrine AB	INDUSTRY
Phadia AB	UNKNOWN
Meda AB

Description Module

Brief Summary

The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptom-guided group	Sham Comparator	Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.	Drug: Single corticosteroid inhalers and Singulair
FeNO-guided group	Active Comparator	Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide	Drug: Single corticosteroid inhalers and Singulair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single corticosteroid inhalers and Singulair	Drug	Treatment steps according to preset algorithm	FeNO-guided group Symptom-guided group

Measure	Description	Time Frame
Mini-AQLQ (Asthma-Related Quality of Life)		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-64
Clinical diagnosis of Asthma
Glucocorticoid treatment > 6 months.
Verified Allergy
Read and speak Swedish

Exclusion Criteria:

Smoking
Current regular treatment with long-acting beta2-agonist
Treatment with Singulair only or in combination with glucocorticoids
Taking part in other research study
Pregnancy or breast-feeding
Unstable Asthma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjell Alving, PhD	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Runby Primary Health Care Center		Upplands Vasby			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D006967	Hypersensitivity
D007249	Inflammation

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