Saline Challenge in Monitoring Asthma Control

October 9, 2013 updated by: Heikki Koskela, Kuopio University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Department of Respiratory Medicine, Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic asthma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in responsiveness to hypertonic saline cough challenge
Time Frame: Before budesonide treatment, and after 1, 4, and 12 weeks' treatment
Before budesonide treatment, and after 1, 4, and 12 weeks' treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5801112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on budesonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe