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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Orion Corporation, Orion Pharma
Sponsor:
Collaborator:
Aerocrine AB
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01783132
First received: January 11, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Device: NIOX MINO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Asthma symptoms in correlation to grade of inflammation in airways [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Asthma symptoms in correlation to grade of inflammation in airways [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    To determine if ICS treatment guided by FENO measurement with a device "NIOX MINO" at home will improve QoL, reduce airway inflammation, reduce IgE sensitization to inhalant allergens, normalize FENO, changes in patients behavior, Adverse Events and Serious Adverse Events


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Budesonide
Asthma treated patient with Budesonide for 1 year, 4 different dosage according to measurement of exhaled NO done with NIOX MINO.
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.
No Intervention: Standard of care
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.

Detailed Description:

The design is a pragmatic randomized controlled, open-label, parallel group study Screening visit 1 and visit 2 is separated with a 2-4 week run-in period. At screening visit, Informed Consent is signed and atopic asthma confirmed, spirometry is performed and questionnaires responded to. At visit 2 venous blood samples are taken and serum stored at -20 °C for later transport to Uppsala Biobank, Exhaled NO is measured at both visit using NIOX MINO (blinded in control group).

  • The active group if on combination inhaler, will switch to Giona Easyhaler (same budesonide equivalent as before study entry) and Oxis (same formoterol equivalent as before study entry). These patients will receive a NIOX MINO and will be taught about the adjustment of ICS treatment according to daily exhaled NO measurement at home and a personalized treatment algorithm.
  • The control group will stay on previous controller treatment (only changed if indicated by symptoms at visit) according to usual care.
  • Both groups will switch short-acting beta-2-agonist to Buventol Easyhaler.
  • Both groups will report symptoms (ACQ) monthly and in connection to asthma events via an ePRO system (ViedocMe, PCG). Active group will report NO values on a weekly basis via the same system.

There will be a follow-up clinic visit 3 at 6 months with exhaled NO measurement (blinded in control group) and limited set of questionnaires. A second follow-up visit 4 at 12 months with exhaled NO, spirometry, full set of questionnaires and blood sample will be made.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01783132

Contacts
Contact: Christer Jansson, Prof. +46 18 611 4115 christer.jansson@medsci.uu.se
Contact: Kjell Alving, Dr +46 706 59 88 70 kjell.alving@aerocrine.com

Locations
Sweden
Lungkliniken, Universitetssjukhuset i Uppsala Recruiting
Uppsala, Sweden, 751 85
Contact: Christer Jansson, Prof.    +46 18 611 41 15    christer.jansson@medsci.uu.se   
Contact: Katarina Nisser    +46 18 611 1000    katarina.nisser@medsci.uu.se   
Principal Investigator: Christer Jansson, Prof.         
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Aerocrine AB
Investigators
Study Director: Kjell Alving, Dr Aerocrine AB
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01783132     History of Changes
Other Study ID Numbers: 1852011
Study First Received: January 11, 2013
Last Updated: January 31, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014