Inhaler therapy in smoking asthmatics

Phase 1

• Conditions: Asthma; MedDRA version: 18.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005317-23-GB
• Lead Sponsor: Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-11
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified