Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
Completed
- Conditions
- AsthmaPulmonary Disease, Chronic Obstructive
- Interventions
- Device: CRC-749Device: DiskusDevice: TwisthalerDevice: Miat Monohaler
- Registration Number
- NCT01033669
- Lead Sponsor
- Pfizer
- Brief Summary
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
- Detailed Description
Randomized to device sequence
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dry Powder Inhalers Diskus - Dry Powder Inhalers Twisthaler - Dry Powder Inhalers Miat Monohaler - Dry Powder Inhalers CRC-749 -
- Primary Outcome Measures
Name Time Method Peak Inspiratory Flow Rate Day 3-10
- Secondary Outcome Measures
Name Time Method Pressure Slope Day 3-10 Peak Pressure Drop Day 3-10 Time to Peak Pressure Drop Day 3-10 Inhaled Volume Day 3-10
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇩🇪Berlin, Germany