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

August 14, 2012 updated by: Karolinska Institutet

Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Upplands Väsby, Sweden
        • Runby Primary Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Symptom-guided group
Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.
Drug: Single corticosteroid inhalers and Singulair
Treatment steps according to preset algorithm
Active Comparator: FeNO-guided group
Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide
Drug: Single corticosteroid inhalers and Singulair
Treatment steps according to preset algorithm

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Merck Sharp & Dohme LLC
Uppsala University
The Swedish Research Council
Region Stockholm
Swedish Council for Working Life and Social Research
Aerocrine AB
Meda AB
Phadia AB

Investigators

  • Principal Investigator: Kjell Alving, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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