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

Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739387
• Other study ID #: KFL9501
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: June 27, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Flutiform® pMDI and Breath Actuated Inhaler (BAI)
Both devices contain placebo

Locations

Country	Name	City	State
United Kingdom	BioKinetic Europe Ltd	Belfast
United Kingdom	Glasgow Clinical Research Facility	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI.		Each device will be used on one day only	No
Secondary	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	No
Secondary	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	No
Secondary	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	No