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| Sponsored by: |
Kuopio University Hospital |
|---|---|
| Information provided by: | Kuopio University Hospital |
| ClinicalTrials.gov Identifier: | NCT00859274 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: budesonide |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Single Group Assignment |
| Official Title: | Saline Challenge in Monitoring Asthma Control |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Budesonide: Experimental
All patients receive this treatment to induce a change in asthma control
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Heikki O Koskela, MD | +358 44 717 2795 | heikki.koskela@kuh.fi |
| Finland | |
| Department of Respiratory Medicine, Kuopio University Hospital | |
| Kuopio, Finland, 70211 | |
More Information
| Responsible Party: | Department of Respiratory Medicine, Kuopio University Hospital, Kuopio, Finland ( Heikki Koskela, MD, head of department ) |
| Study ID Numbers: | KUH5801112 |
| Study First Received: | March 10, 2009 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00859274 History of Changes |
| Health Authority: | Finland: National Agency for Medicines |
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Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Asthma Anti-Asthmatic Agents Hormones Glucocorticoids |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
