Saline Challenge in Monitoring Asthma Control

Asthma Clinical Trial

Official title:

Saline Challenge in Monitoring Asthma Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859274
• Other study ID #: KUH5801112
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: October 9, 2013
• Start date: March 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• symptomatic asthma

Exclusion Criteria:

• usage of inhaled or oral corticosteroids

• recent febrile respiratory infection

• severe, unstable asthma

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide
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.

Locations

Country	Name	City	State
Finland	Department of Respiratory Medicine, Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in responsiveness to hypertonic saline cough challenge		Before budesonide treatment, and after 1, 4, and 12 weeks' treatment	No