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Clinical Trials/EUCTR2014-005317-23-GB
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.

Registry
who.int
Start Date
August 11, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside

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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