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

Last updated on November 7, 2019

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Study Location
Pfizer Investigational Site
Berlin, , 10117 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma, Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01033669
Pfizer
Completed
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction

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Descriptive Information
Brief TitleAssessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
Official TitleA Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
Brief SummaryAssessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
Detailed DescriptionRandomized to device sequence
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationAsthma and COPD patients
Condition
  • Asthma
  • Pulmonary Disease, Chronic Obstructive
Intervention
  • 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.
Study Groups/CohortsDry Powder Inhalers
Interventions:
  • Device: CRC-749
  • Device: Diskus
  • Device: Twisthaler
  • Device: Miat Monohaler
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 15, 2010)
57
Original Estimated Enrollment
 (submitted: December 15, 2009)
56
Actual Study Completion DateFebruary 2010
Actual Primary Completion DateFebruary 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01033669
Other Study ID NumbersA9011071
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2010

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