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

NCT01739387 | Completed

• 1 other identifier: KFL9501
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma; COPD

Keywords

Flutiform®; Asthma; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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.

  Each device will be used for one day only

Study Arms (2)

Breath actuated inhaler (BAI)

Placebo. Two to nine puffs on one day only

Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)

Flutiform® pMDI

Placebo. Two to nine puffs on one day only

Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)

Interventions

Flutiform® pMDI and Breath Actuated Inhaler (BAI) DEVICE

Both devices contain placebo

Breath actuated inhaler (BAI); Flutiform® pMDI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Any severe chronic respiratory disease other than asthma and COPD.
• 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.
• Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
• Known sensitivity to inhaler propellant or excipients.
• Participation in a clinical drug study within 30 days of the screening visit.
• Current participation in a clinical study.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (2)

BioKinetic Europe Ltd

Belfast, United Kingdom

Location

Glasgow Clinical Research Facility

Glasgow, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28683212 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: December 3, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

GB (2)