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Saline Challenge in Monitoring Asthma Control

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
budesonide
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic asthma

Exclusion Criteria:

  • usage of inhaled or oral corticosteroids
  • recent febrile respiratory infection
  • severe, unstable asthma

Sites / Locations

  • Department of Respiratory Medicine, Kuopio University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Budesonide

Arm Description

All patients receive this treatment to induce a change in asthma control

Outcomes

Primary Outcome Measures

Changes in responsiveness to hypertonic saline cough challenge

Secondary Outcome Measures

Full Information

First Posted
March 10, 2009
Last Updated
October 9, 2013
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00859274
Brief Title
Saline Challenge in Monitoring Asthma Control
Official Title
Saline Challenge in Monitoring Asthma Control
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide
Arm Type
Experimental
Arm Description
All patients receive this treatment to induce a change in asthma control
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in responsiveness to hypertonic saline cough challenge
Time Frame
Before budesonide treatment, and after 1, 4, and 12 weeks' treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic asthma Exclusion Criteria: usage of inhaled or oral corticosteroids recent febrile respiratory infection severe, unstable asthma
Facility Information:
Facility Name
Department of Respiratory Medicine, Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24294924
Citation
Koskela HO, Purokivi MK. Airway oxidative stress in chronic cough. Cough. 2013 Dec 2;9(1):26. doi: 10.1186/1745-9974-9-26.
Results Reference
derived
PubMed Identifier
23688169
Citation
Koskela 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.
Results Reference
derived

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Saline Challenge in Monitoring Asthma Control

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