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

Pfizer

Status: Completed

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive

Treatments: Device: Diskus; Device: Twisthaler; Device: Miat Monohaler; Device: CRC-749

Study type: Observational

Funder types: Industry

Identifiers

NCT01033669

A9011071

Details and patient eligibility

About

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

Full description

Randomized to device sequence

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

Dry Powder Inhalers

Treatment:

Device: CRC-749

Device: Miat Monohaler

Device: Twisthaler

Device: Diskus