EUCTR2014-005317-23-GB
Active, not recruiting
Phase 1
Effects of ultra-long acting bronchodilator therapy assessed by impulse oscillometry in smoking asthmatics taking inhaled corticosteroids - MAN05 Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside0 sites16 target enrollmentAugust 11, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
- Enrollment
- 16
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female volunteers aged 18\-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms BDP or the equivalent daily)
- •Current smoker
- •FEV1 \> 60 % predicted
- •Ability to give informed consent
- •Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 16
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Other respiratory diseases such as COPD, bronchiectasis or ABPA
- •An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required
- •Any clinically significant medical condition that may endanger the health or safety of the participant
- •Participation in another trial within 30 days before the commencement of the study
- •Pregnancy or lactation
- •Unable to comply with the procedures of the protocol
- •Unable or unwilling to consent
Outcomes
Primary Outcomes
Not specified
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