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OpenTrials
Completed

NCT Number: NCT00859274

Saline Challenge in Monitoring Asthma Control

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Respiratory Medicine, Kuopio University Hospital

Kuopio, 70211, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic asthma

Exclusion criteria

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

Treatment and study plan

Budesonide

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.

Primary outcomes

  1. Changes in responsiveness to hypertonic saline cough challenge

    Time frame: Before budesonide treatment, and after 1, 4, and 12 weeks' treatment

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2009
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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