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Saline Challenge in Monitoring Asthma Control

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ClinicalTrials.gov Identifier: NCT00859274
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):
Heikki Koskela, Kuopio University Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Saline Challenge in Monitoring Asthma Control
Study Start Date : March 2009
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Budesonide
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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in responsiveness to hypertonic saline cough challenge [ Time Frame: Before budesonide treatment, and after 1, 4, and 12 weeks' treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic asthma

Exclusion Criteria:

  • usage of inhaled or oral corticosteroids
  • recent febrile respiratory infection
  • severe, unstable asthma
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859274


Locations
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Finland
Department of Respiratory Medicine, Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heikki Koskela, Respiratory Physician, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00859274     History of Changes
Other Study ID Numbers: KUH5801112
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists