Pulmonary Disease, Chronic ObstructivePhase 2NCT00726479
Safety and Efficacy of 4-weeks Treatment of BIBW 2948 BS in Patients With Chronic Obstructive Bronchitis
A Phase 2 study testing BIBW 2948 BS in people with Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by Boehringer Ingelheim at 24 sites in 3 countries.
Trial summary
The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
- What is being tested?
- BIBW 2948 BS
- How many people
- 0 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Aug 2008to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Male or female patients 40 years of age or older.
- Patients must have a diagnosis of COPD defined by a post-bronchodilator FEV1 < 80% of predicted and FEV1 < 70% of FVC (to be obtained 30 minutes after administration of salbutamol HFA). Predicted normal values will be calculated according to ECSC (R94-1408).
- For Height measured in inches
- Males:
- FEV1 predicted (L) = 4.30 x (height (inches)/39.37) - 0.029 x age (yrs) - 2.49
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- Females:
- FEV1 predicted (L) = 3.95 x [height (inches)/39.37] - 0.025 x age (yrs) - 2.60
- or Height measured in meters
- Males:
- FEV1 predicted (L) = 4.30 x [height (meters)] - 0.029 x age (yrs) - 2.49
- Females:
- FEV1 predicted (L) = 3.95 x [height (meters)] - 0.025 x age (yrs) - 2.60
- Patients must have a diagnosis of chronic bronchitis symptoms i.e., cough and sputum expectoration on most days for at least three months in each of two consecutive years.
- Patients must be a current or ex-smoker with a smoking history of sup or egal to 10 pack years (Patients who have never smoked cigarettes must be excluded).
- Patients must be able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the HandiHaler® device for BIBW 2948 BS.
- Patients must be able to read and understand the questionnaires in the languages provided (English in the U.S., French in France and German in Germany).
Who cannot join
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study.Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defines a significant disease as defined in exclusion criteria No. 1.
- Patients with an acute or chronic hepatitis or alpha one antitrypsin deficiency or other liver disease.
- Patients with an aspartate aminotransferase (AST), alanine aminotransferase (ALT) 1.5 x the upper limit of the normal range will be excluded regardless of the clinical condition. A repeat laboratory evaluation will not be conducted in these patients.
- Patients with history of asthma or allergic rhinitis.
- Patients with history of post-nasal drip the last 3 months prior visit 1.
- Patients with a clinical diagnosis of bronchiectasis.
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- Patients currently treated with expectorants and/or mucolytics drug.
- Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough.
- Patients with any respiratory tract infection or COPD exacerbation in the 30 days prior the visit 1 or during the 1-week period prior to visit 2 (visit 2 will not be postponed and the patient will be discontinued from the study).
- Patients who have had any change in their respiratory medications within the last 6 weeks prior the visit 1.
- Patients with a history of thoracotomy for other reasons should be evaluated as per Exclusion 1.
- Patients with a history of gastroesophageal reflux disease that have changed medication (dose intensification or a change in therapy) to treat this disease within the 6 weeks prior the visit 1.
- Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years.
- Women of childbearing potential or who have not been post-menopausal for a duration for at least 2 years and have not had a hysterectomy or tubal ligation procedure.
- Participation in another trial with an investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study.
- A known hypersensitivity to lactose or any other component of the inhalation capsule or any other components of the inhalation capsule delivery system.
- Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within four weeks prior the visit 1.
- Patients with a significant history of significant alcohol or drug abuse.
- Patients with previous participation in this study.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
France10 sites
1219.4.3306A Boehringer Ingelheim Investigational Site
Béthune
1219.4.3306B Boehringer Ingelheim Investigational Site
Béthune
1219.4.3302A Boehringer Ingelheim Investigational Site
Marseille
1219.4.3303A Boehringer Ingelheim Investigational Site
Montpellier
1219.4.3308A Boehringer Ingelheim Investigational Site
Nice
1219.4.3307A Boehringer Ingelheim Investigational Site
Nîmes
1219.4.3307B Boehringer Ingelheim Investigational Site
Nîmes
1219.4.3301A Boehringer Ingelheim Investigational Site
Paris
1219.4.3305A Boehringer Ingelheim Investigational Site
Toulouse
1219.4.3305B Boehringer Ingelheim Investigational Site
Toulouse
United States8 sites
1219.4.01001 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1219.4.01006 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
1219.4.01003 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1219.4.01007 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1219.4.01008 Boehringer Ingelheim Investigational Site
Rincon, Georgia
1219.4.01004 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1219.4.01002 Boehringer Ingelheim Investigational Site
Stamford, Connecticut
1219.4.01005 Boehringer Ingelheim Investigational Site
Union, South Carolina
Germany6 sites
1219.4.49003 Boehringer Ingelheim Investigational Site
Eisenach
1219.4.49004 Boehringer Ingelheim Investigational Site
Hamburg
1219.4.49001 Boehringer Ingelheim Investigational Site
Hanover
1219.4.49006 Boehringer Ingelheim Investigational Site
Mainz
1219.4.49005 Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen
1219.4.49002 Boehringer Ingelheim Investigational Site
Rüdersdorf
About this study
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.
The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire
- Being tested
- BIBW 2948 BS
- 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
7.5 mg b.i.d, 15mg q.d, 15mg b.i.d
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study will be change in the Cough and Sputum PRO symptom domain scores from baseline (Visit 2) to the end of the 4 weeks treatment period.
Measured: 4 weeks
Secondary outcomes (1)
Cough and Sputum PRO symptom domain scores Cough and Sputum PRO impact domain scores 24 hours sputum wet/dry weight and volume Cough frequency as recorded by electronic recording of thorax movement Interleukin 8 P. Level Cough and Sputum Rating Sc
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726479
- Sponsor's protocol ID
- 1219.4
- Other IDs
- EUDRACT2007-003742-15
- Status last verified
- Mar 2014
- First submitted
- 30 Jul 2008
- Last updated
- 27 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.
- ClinicalTrials.gov ID
- NCT00726479
- Acronym / sponsor ID
- 1219.4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Male or female patients 40 years of age or older.
- Patients must have a diagnosis of COPD defined by a post-bronchodilator FEV1 < 80% of predicted and FEV1 < 70% of FVC (to be obtained 30 minutes after administration of salbutamol HFA). Predicted normal values will be calculated according to ECSC (R94-1408).
- For Height measured in inches
- FEV1 predicted (L) = 4.30 x (height (inches)/39.37) - 0.029 x age (yrs) - 2.49
Key exclusion criteria (19 listed)
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study.Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defines a significant disease as defined in exclusion criteria No. 1.
- Patients with an acute or chronic hepatitis or alpha one antitrypsin deficiency or other liver disease.
- Patients with an aspartate aminotransferase (AST), alanine aminotransferase (ALT) 1.5 x the upper limit of the normal range will be excluded regardless of the clinical condition. A repeat laboratory evaluation will not be conducted in these patients.
- Patients with history of asthma or allergic rhinitis.
- Patients with history of post-nasal drip the last 3 months prior visit 1.
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 BS7.5 mg b.i.d, 15mg q.d, 15mg b.i.d | Drug | – |
Primary outcome
The primary endpoint of this study will be change in the Cough and Sputum PRO symptom domain scores from baseline (Visit 2) to the end of the 4 weeks treatment period.
Time frame: 4 weeks
1 secondary outcome
Cough and Sputum PRO symptom domain scores Cough and Sputum PRO impact domain scores 24 hours sputum wet/dry weight and volume Cough frequency as recorded by electronic recording of thorax movement Interleukin 8 P. Level Cough and Sputum Rating Sc
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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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
24 sites in 3 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 24 sites in 3 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 18 inclusion and 19 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: withdrawn, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint of this study will be change in the Cough and Sputum PRO symptom domain scores from baseline (Visit 2) to the end of the 4 weeks treatment period. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2014.