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Safety and Efficacy of 4-weeks Treatment of BIBW 2948 BS in Patients With Chronic Obstructive Bronchitis

26 marzo 2014 aggiornato da: Boehringer Ingelheim

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

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Droga: BIBW 2948 BS

Tipo di studio

Interventistico

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Francia
- - Bethune Cedex, Francia
    - 1219.4.3306A Boehringer Ingelheim Investigational Site
  - Bethune Cedex, Francia
    - 1219.4.3306B Boehringer Ingelheim Investigational Site
  - Marseille, Francia
    - 1219.4.3302A Boehringer Ingelheim Investigational Site
  - Montpellier, Francia
    - 1219.4.3303A Boehringer Ingelheim Investigational Site
  - Nice Cedex 1, Francia
    - 1219.4.3308A Boehringer Ingelheim Investigational Site
  - Nimes, Francia
    - 1219.4.3307A Boehringer Ingelheim Investigational Site
  - Nimes, Francia
    - 1219.4.3307B Boehringer Ingelheim Investigational Site
  - Paris Cedex 04, Francia
    - 1219.4.3301A Boehringer Ingelheim Investigational Site
  - Toulouse Cedex, Francia
    - 1219.4.3305A Boehringer Ingelheim Investigational Site
  - Toulouse Cedex, Francia
    - 1219.4.3305B Boehringer Ingelheim Investigational Site
Germania
- - Eisenach, Germania
    - 1219.4.49003 Boehringer Ingelheim Investigational Site
  - Hamburg, Germania
    - 1219.4.49004 Boehringer Ingelheim Investigational Site
  - Hannover, Germania
    - 1219.4.49001 Boehringer Ingelheim Investigational Site
  - Mainz, Germania
    - 1219.4.49006 Boehringer Ingelheim Investigational Site
  - Rodgau-Dudenhofen, Germania
    - 1219.4.49005 Boehringer Ingelheim Investigational Site
  - Ruedersdorf, Germania
    - 1219.4.49002 Boehringer Ingelheim Investigational Site
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti
    - 1219.4.01001 Boehringer Ingelheim Investigational Site
- Arizona
  - Phoenix, Arizona, Stati Uniti
    - 1219.4.01007 Boehringer Ingelheim Investigational Site
- Colorado
  - Fort Collins, Colorado, Stati Uniti
    - 1219.4.01006 Boehringer Ingelheim Investigational Site
- Connecticut
  - Stamford, Connecticut, Stati Uniti
    - 1219.4.01002 Boehringer Ingelheim Investigational Site
- Georgia
  - Rincon, Georgia, Stati Uniti
    - 1219.4.01008 Boehringer Ingelheim Investigational Site
- South Carolina
  - Greenville, South Carolina, Stati Uniti
    - 1219.4.01003 Boehringer Ingelheim Investigational Site
  - Spartanburg, South Carolina, Stati Uniti
    - 1219.4.01004 Boehringer Ingelheim Investigational Site
  - Union, South Carolina, Stati Uniti
    - 1219.4.01005 Boehringer Ingelheim Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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
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).

Exclusion Criteria:

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.
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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Modello interventistico: Assegnazione parallela

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Lasso di tempo
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. Lasso di tempo: 4 weeks	4 weeks

Misure di risultato secondarie

Misura del risultato	Lasso di tempo
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 Lasso di tempo: 4 weeks	4 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2008

Completamento primario (Effettivo)

1 settembre 2008

Completamento dello studio

7 dicembre 2022

Date di iscrizione allo studio

Primo inviato

30 luglio 2008

Primo inviato che soddisfa i criteri di controllo qualità