Effects of Particle Size in Small Airway Dysfunction

Randomised controlled single and chronic dosing crossover comparison of extra fine particle formoterol and coarse particle salmeterol in asthmatic patients with persistent small airways dysfunction - MAN03 Effects of Particle Size in Small Airways Dysfunction Version 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001103-36-GB

Enrollment

Registered

2013-06-03

Start date

2013-05-27

Completion date

Unknown

Last updated

2015-08-04

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: Atimos Modulite Product Name: Atimos Modulite Pharmaceutical Form: Inhalation vapour, emulsion INN or Proposed INN: formoterol fumarate dihydrate CAS Number: 73573-87-2 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female volunteers aged at least 16 years with a diagnosis of asthma Persistent severe small airways dysfunction on impulse oscillometry with R5 > 150% and R5-R20 > 0.05 kPa/L.s despite taking ICS or ICS / LABA FEV1 > 60 % 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: Participants already receiving extra-fine particle LABA Other respiratory diseases such as COPD, bronchiectasis or allegic bronchopulmonary aspergillosis An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement Smoking within one year or 10 pack year history 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effects of extra fine particle formoterol (Atimos) with coarse particle salmeterol (Serevent) on small airway function;Secondary Objective: ;Primary end point(s): Change in R5-R20 as change from baseline after first dose;Timepoint(s) of evaluation of this end point: 24 hours	—

Secondary

Measure	Time frame
Secondary end point(s): Remaining IOS variables (R5,R20,X5,AX,RF) Change in R5-R20 from baseline after chronic dosing Area under the curve for IOS and spirometry from 0 to 60 min (AUC0–60) Spirometry (FEV1, FEF 25-75, FVC) Domiciliary PEF ACQ FeNO;Timepoint(s) of evaluation of this end point: After single dose (24 hours after first dose) and after chronic dosing (1 to 2 weeks after the first dose)	—

Measure

Time frame

Secondary end point(s): Remaining IOS variables (R5,R20,X5,AX,RF) Change in R5-R20 from baseline after chronic dosing Area under the curve for IOS and spirometry from 0 to 60 min (AUC0–60) Spirometry (FEV1, FEF 25-75, FVC) Domiciliary PEF ACQ FeNO;Timepoint(s) of evaluation of this end point: After single dose (24 hours after first dose) and after chronic dosing (1 to 2 weeks after the first dose)

—

Countries

United Kingdom

Contacts

Public ContactArvind Deva Manoharan

University of Dundee

a.d.manoharan@dundee.ac.uk01382 383235

Outcome results

None listed

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