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Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 24, 2009
Last updated: March 15, 2010
Last verified: March 2010
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: CRC-749
Device: Diskus
Device: Twisthaler
Device: Miat Monohaler
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Peak Inspiratory Flow Rate [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pressure Slope [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]
  • Peak Pressure Drop [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]
  • Time to Peak Pressure Drop [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]
  • Inhaled Volume [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dry Powder Inhalers Device: CRC-749
There is no drug being used. This is a device.
Device: Diskus
There is no drug being used. This is a device.
Device: Twisthaler
There is no drug being used. This is a device.
Device: Miat Monohaler
There is no drug being used. This is a device.

Detailed Description:
Randomized to device sequence

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma and COPD patients

Inclusion Criteria:

  • Subjects with a physician documented history or diagnosis of asthma for at least 6 months
  • Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
  • Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

  • Female subjects who are pregnant
  • Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
  • Evidence of lower respiratory tract infection
  • Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis
  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 identifier: NCT01033669

Pfizer Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01033669     History of Changes
Other Study ID Numbers: A9011071 
Study First Received: September 24, 2009
Last Updated: March 15, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Pfizer:
Inhalation profiles

Additional relevant MeSH terms:
Lung Diseases
Respiratory Aspiration
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiration Disorders
Pathologic Processes
Disease Attributes processed this record on October 25, 2016