Pulmonary Disease, Chronic ObstructivePhase 2NCT00423137
Effect of BIBW 2948 BS in COPD
A Phase 2 study testing BIBW 2948 BS in people with Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by Boehringer Ingelheim at 6 sites in 2 countries.
Trial summary
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
- What is being tested?
- BIBW 2948 BS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Jan 2007to 9 Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD smokers
- ages between 40 and 70
Who cannot join
- Significant other diseases
- abnormal hematology
- abnormal liver function
- psychiatric disorders
- pulmonary obstruction
- asthma, allergic rhinitis
Show all 11Show fewer
- dependance on oxygen
- patients with history of myocardial infarction
- patients with history of cancer
- women of child bearing potential
- antiplatelet or anticoagulation therapy
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
1219.5.03 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1219.5.02 Boehringer Ingelheim Investigational Site
Denver, Colorado
1219.5.04 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1219.5.01 Boehringer Ingelheim Investigational Site
San Francisco, California
Germany2 sites
1219.5.06 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
1219.5.05 Boehringer Ingelheim Investigational Site
Hanover
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of a 4-week Treatment of 15 and 30 mg b.i.d BIBW2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) on Epithelial Mucin Stores and the Safety and Efficacy in COPD Patients With Symptoms Associated With Chronic Bronchitis
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
- Being tested
- BIBW 2948 BS, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2948 BSDrug
Capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo - low dose | Placebo comparator | Twice daily (b.i.d.) Receives: Drug: Placebo |
| Placebo - high dose | Placebo comparator | Twice daily (b.i.d.) Receives: Drug: Placebo |
| BIBW2948 - low dose | Experimental | Twice daily (b.i.d.) Receives: Drug: BIBW 2948 BS |
| BIBW2948 - high dose | Experimental | Twice daily (b.i.d.) Receives: Drug: BIBW 2948 BS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Change from baseline of volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies. The volume of mucin per volume of epithelium (Vv mu, ep), as measured by stereological quantification of AB/PAS staining in endobronchial biopsies was performed at baseline (visit 2) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Change from baseline in bronchoalveolar lavage (BAL) cell differential (in %). Differential cell counts were performed on bronchoalveolar lavage samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Change from baseline in bronchoalveolar lavage (BAL) cell count. Total cell counts were performed on bronchoalveolar lavage (BAL) samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment.
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings
Change from baseline in log MUC2 Mucin gene expression (RNA) obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC2) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings
Change from baseline in log mucin gene (MUC5AC) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC5AC) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings
Change from baseline in log mucin gene (MUC5B) expression level obtained in epithelial brushings.
Gene expression levels of the gel-forming mucins (MUC5B) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings
Change from baseline in log mucin gene (MUC8) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC8) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker
Change in percentage of cells with bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus
Change in number of EGRF spots at nucleus. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker
Change in number of EGRF spots with marker per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker
Change in total area bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots
Change in number of EGFR spots per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker
Change in number of EGFR spots at nucleus per cell with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2*100).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina
Change from baseline in number of goblet cells per surface area of basel lamina, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Number of Goblet Cells Per Volume of Epithelium
Change from baseline in number of goblet cells per volume of epithelium, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and visit 5.
Change From Baseline in Goblet Cell Volume
Change from baseline in goblet cell volume, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and visit 5.
Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage
Change from baseline of Interleukin-8 (IL-8) levels in bronchoalveolar lavage. IL-8 levels, were measured by enzyme linked immunosorbent assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage
Change from baseline in Myeloperoxidase (MPO) levels in bronchoalveolar lavage. Myeloperoxidase (MPO) activity levels were measured by enzyme linked immunosorbent or radioimmunoassay assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Measured: At baseline (visit 2) and at visit 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start17 Jan 2007
- Primary completion9 Jul 2008
- Study completion9 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423137
- Sponsor's protocol ID
- 1219.5
- Other IDs
- 2006-001975-40
- Status last verified
- Oct 2021
- First submitted
- 17 Jan 2007
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20007923
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of a 4-week Treatment of 15 and 30 mg b.i.d BIBW2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) on Epithelial Mucin Stores and the Safety and Efficacy in COPD Patients With Symptoms Associated With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00423137
- Acronym / sponsor ID
- 1219.5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2007 (actual)
- Primary completion
- 9 Jul 2008 (actual)
- Study completion
- 9 Jul 2008 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo - low dose | Placebo comparator | Drug: PlaceboTwice daily (b.i.d.) |
| Placebo - high dose | Placebo comparator | Drug: PlaceboTwice daily (b.i.d.) |
| BIBW2948 - low dose | Experimental | Drug: BIBW 2948 BSTwice daily (b.i.d.) |
| BIBW2948 - high dose | Experimental | Drug: BIBW 2948 BSTwice daily (b.i.d.) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD smokers
- ages between 40 and 70
Key exclusion criteria (11 listed)
- Significant other diseases
- abnormal hematology
- abnormal liver function
- psychiatric disorders
- pulmonary obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBW 2948 BSCapsule | Drug | BIBW2948 - high dose, BIBW2948 - low dose |
| PlaceboCapsule | Drug | Placebo - high dose, Placebo - low dose |
Primary outcome
Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina
Time frame: At baseline (visit 2) and at visit 5.
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).
18 secondary outcomes
Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Number of Goblet Cells Per Volume of Epithelium
Time frame: At baseline (visit 2) and visit 5.
Change From Baseline in Goblet Cell Volume
Time frame: At baseline (visit 2) and visit 5.
Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage
Time frame: At baseline (visit 2) and at visit 5.
Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage
Time frame: At baseline (visit 2) and at visit 5.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20007923Woodruff 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBW 2948 BS in people with Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by Boehringer Ingelheim at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina (time frame: At baseline (visit 2) and at visit 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.