Saline Challenge in Monitoring Asthma Control
1 other identifier
interventional
40
1 country
1
Brief Summary
It is generally accepted that symptoms and lung function are not sufficient ways to monitor asthma control. Therefore, several objective tests have been developed to help asthma control monitoring, each having their own shortcomings. We have developed a new test, the hypertonic saline cough challenge. In our previous publication this test has proven useful in diagnosing asthma. The present study is planned to investigate whether hypertonic saline cough challenge could be used to monitor asthma control. A group of steroid-naive asthmatics will be recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at regular intervals utilising a validated questionnaire. At the same time points, hypertonic saline cough challenges will be performed. We will analyse whether changes in the responsiveness to the cough challenge reflects the changes in asthma control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Mar 2009
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 10, 2013
October 1, 2013
4.6 years
March 10, 2009
October 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in responsiveness to hypertonic saline cough challenge
Before budesonide treatment, and after 1, 4, and 12 weeks' treatment
Study Arms (1)
Budesonide
EXPERIMENTALAll patients receive this treatment to induce a change in asthma control
Interventions
Budesonide is given via inhalation utilising a dry powder inhaler called Easyhaler. The dosage is 400 ug twice daily. The duration of the study is 12 weeks but very probably the patients continue the usage of this drug as a part of their routine clinical management.
Eligibility Criteria
You may qualify if:
- symptomatic asthma
You may not qualify if:
- usage of inhaled or oral corticosteroids
- recent febrile respiratory infection
- severe, unstable asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Respiratory Medicine, Kuopio University Hospital
Kuopio, 70211, Finland
Related Publications (2)
Koskela HO, Purokivi MK. Airway oxidative stress in chronic cough. Cough. 2013 Dec 2;9(1):26. doi: 10.1186/1745-9974-9-26.
PMID: 24294924DERIVEDKoskela HO, Purokivi MK. Capability of hypertonic saline cough provocation test to predict the response to inhaled corticosteroids in chronic cough: a prospective, open-label study. Cough. 2013 May 20;9:15. doi: 10.1186/1745-9974-9-15. eCollection 2013.
PMID: 23688169DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Respiratory Physician
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 11, 2009
Study Start
March 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 10, 2013
Record last verified: 2013-10