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

NCT01783132 | Terminated

• 1 other identifier: 1852011
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma symptoms in correlation to grade of inflammation in airways

  To determine if ICS treatment guided by daily FENO measurement with a device "NIOX MINO" at home will improve asthma symptom control compared to usual care asthma management

  Up to 1 year

Study Arms (2)

Budesonide

OTHER

Asthma treated patient with Budesonide for 1 year, 4 different dosage according to measurement of exhaled NO done with NIOX MINO.

Device: NIOX MINO

Standard of care

NO INTERVENTION

Asthma treated patient with standard of care during 1 year. Exhaled NO measurement will be done 4 times/year, and compared afterwards with the Budesonide group.

Interventions

NIOX MINO DEVICE

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.

Budesonide

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18, ≤64 years
• Physician-diagnosis of asthma
• Regular inhaled budesonide (Giona Easyhaler, Pulmicort Turbuhaler, Novopulmon Novolizer or Symbicort Turbuhaler) treatment since at least 6 months
• Verified allergy to at least one airborne perennial allergen after objective testing (ImmunoCAP Rapid Asthma/Rhinitis Adult)
• ACQ \>1.0
• Can read and understand the Swedish language
• Written informed consent signed

You may not qualify if:

• Regular tobacco use within past 6 months
• ≥10 pack-years smoking history
• Keeping a furred pet at home
• Treatment with Singulair
• \>4 prednisolone courses last 12 months
• Ongoing pregnancy or lactation
• Participation in another clinical trial

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead
• Aerocrine AB: collaborator

Study Sites (1)

Lungkliniken, Universitetssjukhuset i Uppsala

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kjell Alving, Dr

  Aerocrine AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SOC

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: February 4, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 28, 2014
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

SE (1)