NCT01176747

Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients

In-vivo Deposition Measurement of Beclometasone and Formoterol After Inhalation of a Single Dose of the Combination BDP Plus Formoterol NEXT DPI in Healthy Volunteers, Asthmatic and COPD Patients.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Asthma

Interventions

Type	Name	Description
DRUG	BDP/formoterol NEXT DPI	Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2010-08-06
• Last updated: 2021-10-29

Locations

1 site across 1 country: Germany