Asthma, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Inhalation profiles, asthma, COPD
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
Interventions
DEVICECRC-749
There is no drug being used. This is a device.
DEVICEDiskus
There is no drug being used. This is a device.
DEVICETwisthaler
There is no drug being used. This is a device.
DEVICEMiat Monohaler
There is no drug being used. This is a device.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Inspiratory Flow Rate | Day 3-10 |
Secondary
| Measure | Time frame |
|---|---|
| Pressure Slope | Day 3-10 |
| Peak Pressure Drop | Day 3-10 |
| Time to Peak Pressure Drop | Day 3-10 |
| Inhaled Volume | Day 3-10 |
Countries
Germany
Outcome results
None listed