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

NCT ID: NCT00421018

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Allergic Asthma

Keywords

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Asthma Allergy Cytokines Glucocorticoids Inflammation Nitric Oxide (NO) Quality of Life Self-Rated Health Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Symptom-guided group

Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.

Group Type SHAM_COMPARATOR

Single corticosteroid inhalers and Singulair

Intervention Type DRUG

Treatment steps according to preset algorithm

FeNO-guided group

Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide

Group Type ACTIVE_COMPARATOR

Single corticosteroid inhalers and Singulair

Intervention Type DRUG

Treatment steps according to preset algorithm

Interventions

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Single corticosteroid inhalers and Singulair

Treatment steps according to preset algorithm

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Aerocrine AB

INDUSTRY

Sponsor Role collaborator

Phadia AB

UNKNOWN

Sponsor Role collaborator

Meda AB

UNKNOWN

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Principal Investigators

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Kjell Alving, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Runby Primary Health Care Center

Upplands Vasby, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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20050166

Identifier Type: -

Identifier Source: org_study_id