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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
Merck Sharp & Dohme Corp.
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
  Purpose
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

Condition Intervention
Allergic Asthma
Drug: Single corticosteroid inhalers and Singulair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Mini-AQLQ (Asthma-Related Quality of Life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: November 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421018

Locations
Sweden
Runby Primary Health Care Center
Upplands Väsby, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Aerocrine AB
Phadia AB
Meda AB
The Swedish Research Council
Swedish Council for Working Life and Social Research
Merck Sharp & Dohme Corp.
Uppsala University
Investigators
Principal Investigator: Kjell Alving, PhD Uppsala University
  More Information

Responsible Party: Kjell Alving/ Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT00421018     History of Changes
Other Study ID Numbers: 20050166 
Study First Received: January 10, 2007
Last Updated: August 14, 2012
Health Authority: Sweden: The Ministry of Education and Cultural Affairs

Keywords provided by Karolinska Institutet:
Asthma
Allergy
Cytokines
Glucocorticoids
Inflammation
Nitric Oxide (NO)
Quality of Life
Self-Rated Health
Stress

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers

ClinicalTrials.gov processed this record on September 28, 2016