Effects of Particle Size in Small Airways Dysfunction

NCT01892787 | Completed Phase 4

• 3 other identifiers: 2013RC012013-001103-3613/ES/0050
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Keywords

Asthma; Small airways; Extra fine particle long-acting beta agonists

Outcome Measures

Primary Outcomes (1)

• Change in R5-R20 as change from baseline after first and last dose

  R5 - Resistance at 5Hz, R20 - Resistance at 20Hz

  At baseline & after 1-2 weeks

Secondary Outcomes (6)

• Change in remaining impulse oscillometry variables (R5,R20,X5,AX,RF) after first and last dose

  Baseline and after 1-2 weeks

• Area under the curve from 0 to 60 min

  Baseline and 1-2 weeks

• Spirometry

  Baseline & 1-2 weeks

• Domiciliary peak expiratory flow

  1-2 weeks

• Asthma Control Questionnaire

  1-2 weeks

Study Arms (2)

Formoterol (Atimos Modulite)

EXPERIMENTAL

Atimos Modulite 1 puff (12 micrograms) twice a day

Drug: Formoterol

Salmeterol (Serevent Accuhaler)

ACTIVE COMPARATOR

Serevent Accuhaler 1 puff (50 micrograms) of twice a day

Drug: Salmeterol

Interventions

Formoterol DRUG

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

Also known as: Atimos Modulite

Formoterol (Atimos Modulite)

Salmeterol DRUG

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

Also known as: Serevent Accuhaler

Salmeterol (Serevent Accuhaler)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 inhaled corticosteroids / long-acting beta-agonists
• 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

You may not qualify if:

• Participants already receiving extra-fine particle long-acting beta agonists
• Other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or alergic allergic 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

Sponsors & Collaborators

• University of Dundee: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

Brian Lipworth

Dundee, DD1 3AU, United Kingdom

Location

Related Publications (1)

• Manoharan A, von Wilamowitz-Moellendorff A, Morrison A, Lipworth BJ. Effects of formoterol or salmeterol on impulse oscillometry in patients with persistent asthma. J Allergy Clin Immunol. 2016 Mar;137(3):727-33.e1. doi: 10.1016/j.jaci.2015.06.012. Epub 2015 Jul 26.

  PMID: 26220533 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Albuterol; Phenethylamines; Ethylamines

Study Officials

• Brian Lipworth, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Arvind Deva Manoharan, MBChB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Allergy and Pulmonolgy

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 4, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)