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Saline Challenge in Monitoring Asthma Control

NCT ID: NCT00859274

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Budesonide

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

Group Type EXPERIMENTAL

budesonide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* symptomatic asthma

Exclusion Criteria

* usage of inhaled or oral corticosteroids
* recent febrile respiratory infection
* severe, unstable asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heikki Koskela

Respiratory Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Respiratory Medicine, Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Koskela HO, Purokivi MK. Airway oxidative stress in chronic cough. Cough. 2013 Dec 2;9(1):26. doi: 10.1186/1745-9974-9-26.

Reference Type DERIVED
PMID: 24294924 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23688169 (View on PubMed)

Other Identifiers

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KUH5801112

Identifier Type: -

Identifier Source: org_study_id