Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Orion Corporation, Orion Pharma.
Recruitment status was:  Recruiting
Aerocrine AB
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma Identifier:
First received: January 11, 2013
Last updated: January 31, 2013
Last verified: January 2013

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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
    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 ]
    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
Asthma treated patient with Budesonide for 1 year, 4 different dosage according to measurement of exhaled NO done with 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.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01783132

Contact: Christer Jansson, Prof. +46 18 611 4115
Contact: Kjell Alving, Dr +46 706 59 88 70

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

Responsible Party: Orion Corporation, Orion Pharma Identifier: NCT01783132     History of Changes
Other Study ID Numbers: 1852011
Study First Received: January 11, 2013
Last Updated: January 31, 2013

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017