Efficacy study of Faulding's sea cucumber extracts in mild to moderate adult asthma

Phase 3

Completed

• Conditions: Mild to moderate asthma; Respiratory - Asthma

• Registration Number: ACTRN12605000234617
• Lead Sponsor: Fauldings Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Greater than or equal to 10% improvement in FEV1 after administration of 200mcg inhaled salbutamol sulphate (=2 puffs) NOT less than 6 hours after previous use of inhaled salbutamol sulphate; non-smoking; FEV1 greater than 60% of the predicted value for age and sex; subjects who have given their informed written consent; subjects who have at least one asthma symptom (cough or wheeze) per week; subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.

Exclusion Criteria

Severe asthma as defined by the National Asthma Campaign (1998) -refer to attached handbook; any other clinically significant respiratory disease; a history of acute upper or lower respiratory tract infection within 4 weeks of starting the study; a history of oral or inhaled steroid use or leukotriene receptor antagonists within 3 months of starting the study; female subjects who are pregnant or lactating; subjects with contra-indications to the study medications; any clinically significant abnormality or disease associated with significant respiratory morbidity; subjects with any condition that, in the opinion of the investigator could be detrimental to the health of the subjects or might interfere with the evaluation of the study objective.

Study & Design

• Study Type: Interventional
• Study Design: Not specified