NCT00267917

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
26 days until next milestone

Study Start

First participant enrolled

January 17, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2006

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

December 21, 2005

Last Update Submit

December 7, 2023

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the percentage of lung deposition achieved with natural inhaler technique compared with supervised optimal administration.

    up to 6 weeks

Secondary Outcomes (6)

  • Central lung zone deposition

    8 weeks

  • Intermediate lung zone deposition

    8 weeks

  • Peripheral lung zone deposition

    8 weeks

  • Ratio of peripheral lung zone to central lung zone deposition

    8 weeks

  • Oropharyngeal deposition

    8 weeks

  • +1 more secondary outcomes

Interventions

Berodual RespimatDEVICE
Berodual HFA-MDIDEVICE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients: FEV1 less or equal 65% pre FEV1 less or equal 70% of FVC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inamed Research GmbH & Co. KG

Gauting, 82131, Germany

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Boehringer Ingelheim Study Coordinator

    B.I. Pharma GmbH & Co. KG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

January 17, 2006

Primary Completion

February 27, 2006

Study Completion

February 27, 2006

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

DE(1)