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

March 15, 2010 updated by: Pfizer

A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized to device sequence

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Asthma and COPD patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Inspiratory Flow Rate
Time Frame: Day 3-10
Day 3-10

Secondary Outcome Measures

Outcome Measure
Time Frame
Pressure Slope
Time Frame: Day 3-10
Day 3-10
Peak Pressure Drop
Time Frame: Day 3-10
Day 3-10
Time to Peak Pressure Drop
Time Frame: Day 3-10
Day 3-10
Inhaled Volume
Time Frame: Day 3-10
Day 3-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 17, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9011071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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