Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT01783132
Status:
TERMINATED
Last Update Posted:
2019-09-06
First Post:
2013-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home
Sponsor:
Orion Corporation, Orion Pharma
Organization:
Study Overview
Official Title:
Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changing conditions for the device in one of the participation companies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTAGEN
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.
To understand changes in patient behaviour triggered by daily FENO measurement at home, for example treatment adherence and voluntary allergen exposure.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: