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

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Aerocrine AB
Phadia AB
Meda AB
The Swedish Research Council
Swedish Council for Working Life and Social Research
MSD Sweden
Uppsala University
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00421018
First received: January 10, 2007
Last updated: August 14, 2012
Last verified: August 2012
History of Changes

January 10, 2007
August 14, 2012
November 2006
April 2010   (final data collection date for primary outcome measure)
Mini-AQLQ (Asthma-Related Quality of Life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mini-AQLQ (Asthma-Related Quality of Life)
Complete list of historical versions of study NCT00421018 on ClinicalTrials.gov Archive Site
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Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)
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
Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Allergic Asthma
Drug: Single corticosteroid inhalers and Singulair
Treatment steps according to preset algorithm
  • Sham Comparator: Symptom-guided group
    Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.
    Intervention: Drug: Single corticosteroid inhalers and Singulair
  • Active Comparator: FeNO-guided group
    Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide
    Intervention: Drug: Single corticosteroid inhalers and Singulair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00421018
20050166
Not Provided
Kjell Alving/ Professor, Uppsala University
Karolinska Institutet
  • Stockholm County Council, Sweden
  • Aerocrine AB
  • Phadia AB
  • Meda AB
  • The Swedish Research Council
  • Swedish Council for Working Life and Social Research
  • MSD Sweden
  • Uppsala University
Principal Investigator: Kjell Alving, PhD Uppsala University
Karolinska Institutet
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP