Inhaler Therapy in Asthmatics

Proof of concept study to evaluate single and chronic dosing effects of ultra-long acting bronchodilator therapy on mannitol challenge in asthmatic patients taking inhaled corticosteroids - MAN02 Ultra-long Acting Bronchodilator Therapy in Asthmatics Version 1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001953-28-GB

Enrollment

Registered

2013-07-04

Start date

2013-08-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 16.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855

Interventions

Trade Name: Onbrez Breezhaler Product Name: Onbrez Breezhaler (indacaterol) Pharmaceutical Form: Inhalation powder INN or Proposed INN: indacaterol maleate CAS Number: 753498-25-8 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female volunteers aged at least 16 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms of beclomethasone dipropionate or the equivalent daily) FEV1 > 50 % predicted Mannitol PD15 = 635 mg 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 14 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 chronic obstructive pulmonary disease(COPD), bronchiectasis or allergic bronchopulmonary aspergillosis (ABPA) An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement Any clinically significant medical condition that may endanger the health or safety of the participant Smoking within one year or >10 pack year history 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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 24 hours (single dose) 2-4 weeks (chronic dosing);Main Objective: To compare first and last dose protection against mannitol challenge for indacaterol alone versus indacaterol plus tiotropium given once daily as add-on therapy to pre-existing inhaled corticosteroids.;Secondary Objective: To compare the bronchodilator response with indacaterol versus indacaterol plus tiotropium;Primary end point(s): Change in mannitol PD15 from baseline after single and chronic dosing comparing indacaterol alone and indacaterol plus tiotropium.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 24 hours (single dose) 2-4 weeks (chronic dosing);Main Objective: To compare first and last dose protection against mannitol challenge for indacaterol alone versus indacaterol plus tiotropium given once daily as add-on therapy to pre-existing inhaled corticosteroids.;Secondary Objective: To compare the bronchodilator response with indacaterol versus indacaterol plus tiotropium;Primary end point(s): Change in mannitol PD15 from baseline after single and chronic dosing comparing indacaterol alone and indacaterol plus tiotropium.

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Secondary

Measure	Time frame
Secondary end point(s): Mannitol RDR Salbutamol recovery time following mannitol challenge. Domiciliary PEF Trough FEV1 FeNO Trough IOS ACQ;Timepoint(s) of evaluation of this end point: 24 hours (single dose) 2-4 weeks (chronic dosing)	—

Countries

United Kingdom

Contacts

Public ContactLipworth

University of Dundee

brianlipworth@gmail.com01382 383188

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026