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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01033669
First received: September 24, 2009
Last updated: March 15, 2010
Last verified: March 2010
History of Changes
  Purpose

Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction


Condition Intervention Phase
Asthma
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asthma and COPD patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033669

Locations
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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
asthma
COPD

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013