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Effects of Particle Size in Small Airways Dysfunction

NCT01892787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-04-12

No results posted yet for this study

Summary

The airways in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and do not provide information on the smaller 'peripheral' airways. Newer measurements have been developed that can now give us accurate information on how the smaller airways are working. Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing. Recently, new types of inhaler formulations have been developed that have a much smaller particle size than other standard formulations. These formulations have been shown to go further into the lungs, thus getting into the smaller airways. In this study we aim to compare the two extremes of available long acting beta agonists in terms of particle size i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in asthmatics with abnormal small airway function using a breathing test called impulse oscillometry. By using this test we will be able to find out whether using an extrafine particle inhaler improves small airway function.

Conditions

Interventions

DRUG

Formoterol

Participants receive Atimos for 1 to 2 weeks.Partcipants then enter a washout period and after the washout period receive the alternative treatment arm.

DRUG

Salmeterol

Participants receive Serevent for 1 to 2 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY

  • University of Dundee

    lead OTHER

Principal Investigators

  • Brian Lipworth, MD · University of Dundee

  • Arvind Deva Manoharan, MBChB · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892787 on ClinicalTrials.gov