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

Allergic Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421018
• Other study ID #: 20050166
• Status: Completed
• Phase: N/A
• First received: January 10, 2007
• Last updated: August 14, 2012
• Start date: November 2006
• Est. completion date: April 2010

Study information

• Verified date: August 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The Ministry of Education and Cultural Affairs
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Single corticosteroid inhalers and Singulair
Treatment steps according to preset algorithm

Locations

Country	Name	City	State
Sweden	Runby Primary Health Care Center	Upplands Väsby

Sponsors (9)

Lead Sponsor	Collaborator
Karolinska Institutet	Aerocrine AB, Meda AB, Merck Sharp & Dohme Corp., Phadia AB, Stockholm County Council, Sweden, Swedish Council for Working Life and Social Research, The Swedish Research Council, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-AQLQ (Asthma-Related Quality of Life)		1 year	No