Asthma Clinical Trial
Official title:
A Randomised Open Label, Four Way, Cross-over Scintigraphic Evaluation of the Respimat Inhaler vs. a Metered Dose Inhaler (HFA-MDI) Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Poor MDI Technique.
Verified date | December 2023 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this trial is to compare the total and regional deposition of aerosol in the lungs and oropharynx of patients with COPD and known poor MDI inhalation technique following inhalation of Berodual delivered via the Respimat inhaler and Berodual delivered via an HFA-metered dose inhaler achieved with their "natural" inhalation technique compared with taught "optimal" technique.
Status | Completed |
Enrollment | 13 |
Est. completion date | February 27, 2006 |
Est. primary completion date | February 27, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion criteria: COPD patients: FEV1 less or equal 65% pre FEV1 less or equal 70% of FVC Exclusion criteria: Patients with any upper respiratory infection in the past 14 days prior to the screening visit (visit 1) Patients with any unstable or life-threatening cardiac arrhythmia |
Country | Name | City | State |
---|---|---|---|
Germany | Inamed Research GmbH & Co. KG | Gauting |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is the percentage of lung deposition achieved with natural inhaler technique compared with supervised optimal administration. | up to 6 weeks | ||
Secondary | Central lung zone deposition | 8 weeks | ||
Secondary | Intermediate lung zone deposition | 8 weeks | ||
Secondary | Peripheral lung zone deposition | 8 weeks | ||
Secondary | Ratio of peripheral lung zone to central lung zone deposition | 8 weeks | ||
Secondary | Oropharyngeal deposition | 8 weeks | ||
Secondary | FEV1 15, 30 and 60 minutes post-administration (safety only) | 8 weeks |
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