We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421018
First Posted: January 11, 2007
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 10, 2007
First Posted: January 11, 2007
Last Update Posted: August 15, 2012
Last Verified: August 2012

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