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Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home

NCT01783132 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-09-06

No results posted yet for this study

Summary

To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS) controller treatment guided by exhaled NO measurement made at home with usual care asthma management with regard to asthma control (primary outcome), asthma-related quality of life, lung function, airway inflammation, medication use, and asthma events.

To understand changes in patient behaviour triggered by daily FENO measurement at home, for example treatment adherence and voluntary allergen exposure.

Conditions

Interventions

DEVICE

NIOX MINO

Active group (Budesonide) will be measuring exhaled NO at least 3 times/week at home to control their Asthma treatment via a algorithm schedule. The control group (Standard of care) will be measuring exhaled NO 4 times/year at study site.

Sponsors & Collaborators

  • Aerocrine AB

    collaborator INDUSTRY

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Kjell Alving, Dr · Aerocrine AB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-01
Primary Completion
2014-04-01
Completion
2014-04-28

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783132 on ClinicalTrials.gov