NCT00423137

Brief Summary

Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

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

January 17, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2008

Completed
13.4 years until next milestone

Results Posted

Study results publicly available

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

January 17, 2007

Results QC Date

September 6, 2021

Last Update Submit

October 21, 2021

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina

    Change from baseline in volume of mucin per surface area of basal lamina. Volume of mucin per surface area of basal lamina (vs mu,bala) was determined by stereologic quantification of Periodic Acid Schiff's (AB/PAS) reagent staining in endobronchial biopsies at visit 2 (baseline) and at the end of the 4-week period of randomized treatment (visit 5).

    At baseline (visit 2) and at visit 5.

Secondary Outcomes (18)

  • Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies

    At baseline (visit 2) and at visit 5.

  • Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)

    At baseline (visit 2) and at visit 5.

  • Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count

    At baseline (visit 2) and at visit 5.

  • Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings

    At baseline (visit 2) and at visit 5.

  • Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings

    At baseline (visit 2) and at visit 5.

  • +13 more secondary outcomes

Study Arms (4)

Placebo - low dose

PLACEBO COMPARATOR

Twice daily (b.i.d.)

Drug: Placebo

Placebo - high dose

PLACEBO COMPARATOR

Twice daily (b.i.d.)

Drug: Placebo

BIBW2948 - low dose

EXPERIMENTAL

Twice daily (b.i.d.)

Drug: BIBW 2948 BS

BIBW2948 - high dose

EXPERIMENTAL

Twice daily (b.i.d.)

Drug: BIBW 2948 BS

Interventions

BIBW 2948 BSDRUG

Capsule

BIBW2948 - high doseBIBW2948 - low dose
PlaceboDRUG

Capsule

Placebo - high dosePlacebo - low dose

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD smokers
  • ages between 40 and 70

You may not qualify if:

  • Significant other diseases
  • abnormal hematology
  • abnormal liver function
  • psychiatric disorders
  • pulmonary obstruction
  • asthma, allergic rhinitis
  • dependance on oxygen
  • patients with history of myocardial infarction
  • patients with history of cancer
  • women of child bearing potential
  • antiplatelet or anticoagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

1219.5.03 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1219.5.01 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1219.5.02 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1219.5.04 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1219.5.06 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

Location

1219.5.05 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

Related Publications (1)

  • Woodruff PG, Wolff M, Hohlfeld JM, Krug N, Dransfield MT, Sutherland ER, Criner GJ, Kim V, Prasse A, Nivens MC, Tetzlaff K, Heilker R, Fahy JV. Safety and efficacy of an inhaled epidermal growth factor receptor inhibitor (BIBW 2948 BS) in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Mar 1;181(5):438-45. doi: 10.1164/rccm.200909-1415OC. Epub 2009 Dec 10.

    PMID: 20007923DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

January 17, 2007

Primary Completion

July 9, 2008

Study Completion

July 9, 2008

Last Updated

November 19, 2021

Results First Posted

November 19, 2021

Record last verified: 2021-10

Locations

US(4)DE(2)