Asthma MedDRA version: 18.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Striverdi Respimat
Product Name: Striverdi Respimat
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: olodaterol hydrochloride
CAS Number: 868049-49-4
Concentration unit: µg mi
Sponsors
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of olodaterol alone versus olodaterol plus tiotropium given once daily as add-on therapy to pre-existing inhaled corticosteroids using impulse oscillometry in smoking asthmatics ;Secondary Objective: To assess the effects of olodaterol alone versus olodaterol plus tiotropium given once daily as add-on therapy to pre-existing inhaled corticosteroids on spirometry, mannitol challenge, air trapping, airway resistance, domiciliary peak expiratory flow and asthma control in smoking asthmatics ;Primary end point(s): Airway resistance at 5Hz (R5) ;Timepoint(s) of evaluation of this end point: 2-4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): IOS variables (R20,R5-R20,AX,X5 and RF) FEV1 Mannitol PD10 Mannitol RDR FVC at PD10 IOS variables at PD10 Salbutamol recovery time following mannitol challenge RV / TLC Raw Domiciliary PEF ACQ ;Timepoint(s) of evaluation of this end point: 2-4 weeks | — |
Countries
United Kingdom
Contacts
Public ContactBrian Lipworth
Scottish Centre for Respiratory Research, University of Dundee
Outcome results
None listed