NCT00153075

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 at 3 different inspiratory flow rates following inhalation of Berodual delivered via the Respimat inhaler and Berodual? delivered via an HFA-metered dose inhaler.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

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

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
14 days until next milestone

Study Start

First participant enrolled

September 26, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2005

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

September 9, 2005

Last Update Submit

November 27, 2023

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Outcome Measures

Primary Outcomes (1)

  • Whole lung deposition

    12 weeks

Secondary Outcomes (7)

  • Central lung zone deposition

    12 weeks

  • Intermediate lung zone deposition

    10 weeks

  • Peripheral lung zone deposition

    12 weeks

  • Ratio of peripheral to central zone deposition

    12 weeks

  • Oropharyngeal deposition

    12 weeks

  • +2 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

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

September 9, 2005

First Posted

September 12, 2005

Study Start

September 26, 2005

Primary Completion

December 7, 2005

Study Completion

December 7, 2005

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)