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NCT01033669 Clinical Trial

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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01033669
Other study ID # A9011071
Secondary ID
Status Completed
Phase Phase 2
First received September 24, 2009
Last updated March 15, 2010
Start date November 2009
Est. completion date February 2010

Study information
Verified date March 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

Description:

Randomized to device sequence

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• CRC-749
There is no drug being used. This is a device.
• Diskus
There is no drug being used. This is a device.
• Twisthaler
There is no drug being used. This is a device.
• Miat Monohaler
There is no drug being used. This is a device.

Locations
Country Name City State
Germany Pfizer Investigational Site Berlin

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Inspiratory Flow Rate Day 3-10 No
Secondary Pressure Slope Day 3-10 No
Secondary Peak Pressure Drop Day 3-10 No
Secondary Time to Peak Pressure Drop Day 3-10 No
Secondary Inhaled Volume Day 3-10 No
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