Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
1 other identifier
observational
57
1 country
1
Brief Summary
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 17, 2010
March 1, 2010
3 months
September 24, 2009
March 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Inspiratory Flow Rate
Day 3-10
Secondary Outcomes (4)
Pressure Slope
Day 3-10
Peak Pressure Drop
Day 3-10
Time to Peak Pressure Drop
Day 3-10
Inhaled Volume
Day 3-10
Study Arms (1)
Dry Powder Inhalers
Interventions
Eligibility Criteria
Asthma and COPD patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Berlin, 10117, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 24, 2009
First Posted
December 16, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 17, 2010
Record last verified: 2010-03