Targeted Small Airways Therapy in Persistent Asthma

NCT01894048 | Completed Phase 4

• 3 other identifiers: 2012RC162012-003923-3913/ES/0064
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow. The airways (breathing tubes) 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 don't 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 steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control. In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.

Conditions

Asthma

Keywords

asthma control; small airways; extra-fine particle inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Questionnaire score from post-run-in baseline

  8 weeks

Secondary Outcomes (10)

• Impulse oscillometry

  8 weeks

• Spirometry

  8 weeks

• Blood eosinophilic cationic protein

  8 weeeks

• Blood eosinophils

  8 weeks

• Exhaled Nitric Oxide

  8 weeks

Study Arms (1)

Qvar® (beclometasone dipropionate HFA)

EXPERIMENTAL

Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period.

Drug: Qvar® (beclometasone dipropionate HFA)

Interventions

Qvar® (beclometasone dipropionate HFA) DRUG

Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period.

Qvar® (beclometasone dipropionate HFA)

Eligibility Criteria

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

You may qualify if:

• Male and female volunteers aged 18-65, with persistent asthma
• Asthma Control Questionnaire score \>1.0 (at end of run-in)
• FEV1 \>60% predicted
• R5\>130% predicted and R5-R20\>0.03kPa/L/s
• Ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
• Ability to give informed consent
• Asthmatic patients receiving treatment at Step 2, 3, or 4 of British Thoracic Society asthma guidelines
• Ability to withhold long-acting beta-agonists for the duration of the study

You may not qualify if:

• Patients already receiving extra-fine particle inhaled corticosteroids (Qvar, Fostair, Alvesco)
• Pregnancy or lactation
• Known or suspected sensitivity to the Investigational Medicinal Product
• Inability to comply with protocol
• Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
• An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
• Participation in previous trial within 30 days

Sponsors & Collaborators

• University of Dundee: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Brian Lipworth

Dundee, DD1 3AU, United Kingdom

Location

Related Publications (1)

• Kuo CR, Jabbal S, Anderson W, Lipworth BJ. Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control. Clin Exp Allergy. 2019 Oct;49(10):1321-1327. doi: 10.1111/cea.13453. Epub 2019 Aug 6.

  PMID: 31264282 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Brian Lipworth, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

• William Anderson, MBChB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Allergy and Immunology

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: October 28, 2013
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

GB (1)