Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home (OCTAGEN)
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.
|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|
- 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
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783132
|Contact: Christer Jansson, Prof.||+46 18 611 email@example.com|
|Contact: Kjell Alving, Dr||+46 706 59 88 firstname.lastname@example.org|
|Lungkliniken, Universitetssjukhuset i Uppsala||Recruiting|
|Uppsala, Sweden, 751 85|
|Contact: Christer Jansson, Prof. +46 18 611 41 15 email@example.com|
|Contact: Katarina Nisser +46 18 611 1000 firstname.lastname@example.org|
|Principal Investigator: Christer Jansson, Prof.|
|Study Director:||Kjell Alving, Dr||Aerocrine AB|