A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)

A Randomised, Open-label, Cross-over Study of Flutiform® BAI and Flutiform® pMDI Devices in Adolescents and Adult Subjects With Persistent Asthma or Chronic Obstructive Pulmonary Disease (COPD) to Assess Patient Handling.

This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose inhaler) and a breath activated device (BAI). Patient handling will be assessed using assessment criteria which detail the correct handling steps for each inhaler.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)

Detailed Description

Approximately 340 subjects aged 12 years and over who have asthma or chronic obstructive pulmonary disease (COPD), and are on medication for their condition will be recruited for the study. Subjects will be recruited to ensure that different severities of disease are included in the study.

Severity of disease will be determined by predicted FEV1. During the study subjects will be trained to use both the pMDI device and the BAI device being compared. Following training the subjects' use of each device will be assessed by a trainer/assessor using assessment criteria which cover handling, actuation and inhalation aspects for each of the devices under test. The order in which subjects receive each device will be determined using a randomisation schedule.

During the study subjects will continue to take their prescribed asthma or COPD medication. The pMDI and BAI devices used for the patient handling assessment will only contain placebo.

The duration of the study for a subject will be up to 58 days. Training and use of each device will be separated by 7 to 21 days

• Study Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • BioKinetic Europe Ltd
  • Glasgow, United Kingdom
    • Glasgow Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Asthmas and COPD patients aged 12 and above obtained from primary care and advertising in Glasgow and Belfast areas.

Description

Inclusion Criteria:

1. Written informed consent/assent.
2. Male and female subjects ≥12 years old.
3. Documented history of asthma or COPD for ≥ 6 months prior to screening visit.
4. Subjects receiving ICS and LABA
5. Can perform spirometry adequately.
6. Willing and able to attend all study visits

Exclusion Criteria:

1. Any severe chronic respiratory disease other than asthma and COPD.
2. Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the Investigator's opinion, precludes entry into the study or may confound between-period comparisons. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the Subject at risk through study participation.
3. Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
4. Known sensitivity to inhaler propellant or excipients.
5. Participation in a clinical drug study within 30 days of the screening visit.
6. Current participation in a clinical study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breath actuated inhaler (BAI); Placebo. Two to nine puffs on one day only	Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI); Both devices contain placebo
Flutiform® pMDI; Placebo. Two to nine puffs on one day only	Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI); Both devices contain placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of successful device use (Flutiform® pMDI) versus (breath activated device (BAI))	This study compares our Flutiform® pMDI (pressurised metered dose inhaler) containing placebo only and a breath activated device (BAI), containing placebo only. The percentage of subjects will be measured who have successful device use using an 8 point scale.	One day only for each device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI.		Each device will be used on one day only
The percentage of subjects with successful device use	This is defined as all critical steps being correctly performed - Steps 2, 4 - 6 for pMDI; Steps 2, 4 - 7 for BAI; on an 8 point scale	Each device will be used for one day only
The percentage of subjects unable to be trained to use the device successfully within 15 minutes		Each device will be used on one day only
The percentage of subjects able to perform 7, 6, 5, 4, 3, 2, and 1 step successfully.	Measured on an 8 point scale	Each device will be used for one day only

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Publications and helpful links

General Publications

• Bell D, Mansfield L, Lomax M. A Randomized, Crossover Trial Evaluating Patient Handling, Preference, and Ease of Use of the Fluticasone Propionate/Formoterol Breath-Triggered Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Dec;30(6):425-434. doi: 10.1089/jamp.2017.1385. Epub 2017 Jul 6.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Asthma; COPD; Flutiform®
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: KFL9501