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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT01739387
First received: November 14, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Asthma
COPD
Device: Flutiform® pMDI and Breath Actuated Inhaler (BAI)

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • Measurement of successful device use (Flutiform® pMDI) versus (breath activated device (BAI)) [ Time Frame: One day only for each device ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The percentage of subjects able to generate an adequate inspiratory flow to trigger the BAI. [ Time Frame: Each device will be used on one day only ] [ Designated as safety issue: No ]
  • The percentage of subjects with successful device use [ Time Frame: Each device will be used for one day only ] [ Designated as safety issue: No ]
    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

  • The percentage of subjects unable to be trained to use the device successfully within 15 minutes [ Time Frame: Each device will be used on one day only ] [ Designated as safety issue: No ]
  • The percentage of subjects able to perform 7, 6, 5, 4, 3, 2, and 1 step successfully. [ Time Frame: Each device will be used for one day only ] [ Designated as safety issue: No ]
    Measured on an 8 point scale


Enrollment: 332
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739387

Locations
United Kingdom
BioKinetic Europe Ltd
Belfast, United Kingdom
Glasgow Clinical Research Facility
Glasgow, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
  More Information

No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT01739387     History of Changes
Other Study ID Numbers: KFL9501
Study First Received: November 14, 2012
Last Updated: June 27, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Mundipharma Research Limited:
Flutiform®
Asthma
COPD

Additional relevant MeSH terms:
Asthma
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014