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Trial record 1 of 4 for:    BI 1265162
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A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059094
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 15, 2019
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
Efficacy of BI 1265162 is the change from baseline in percent predicted trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Up to 4 weeks ]
Trough FEV1 is defined as measurement performed within 30 minutes prior to dosing
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04059094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Change from baseline in Lung Clearance Index (LCI) assessed by N2 Multiple Breath Washout (N2MBW) procedure [ Time Frame: Up to 4 weeks ]
  • Change from baseline in Cystic Fibrosis Questionnaire Revised (CFQ-R) total score [ Time Frame: Up to 4 weeks ]
  • Change from baseline in Cough and Sputum Assessment Questionnaire (CASA-Q) (4 separate sub-scores) [ Time Frame: Up to 4 weeks ]
  • Percentage of patients with treatment-emergent Adverse Events (AE) [ Time Frame: Up to day 36 ]
  • Ct,N (concentration of the analyte in plasma at time t following dose N) [ Time Frame: Up to day 36 ]
  • Cpre,N (predose concentration measured for dose N) [ Time Frame: Up to day 29 ]
  • AUC0-t,N (area under the concentration-time curve of the analyte in plasma until t hours after dose N) [ Time Frame: Up to day 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Change from baseline in Lung Clearance Index (LCI) assessed by N2 Multiple Breath Washout (N2MBW) procedure [ Time Frame: Up to 4 weeks ]
  • Change from baseline in Cystic Fibrosis Questionnaire Revised (CFQ-R) total score [ Time Frame: Up to 4 weeks ]
  • Change from baseline in Cough and Sputum Assessment Questionnaire (CASA-Q) (4 separate sub-scores) [ Time Frame: Up to 4 weeks ]
  • Percentage of patients with treatment-emergent Adverse Events (AE) [ Time Frame: Up to day 36 ]
  • Cmax,N (maximum measured concentration of the analyte in plasma following dose N) [ Time Frame: Up to day 36 ]
  • Cpre,N (predose concentration measured for dose N) [ Time Frame: Up to day 29 ]
  • AUC0-t,N (area under the concentration-time curve of the analyte in plasma until t hours after dose N) [ Time Frame: Up to day 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1
Brief Summary The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: BI 1265162
    Inhalation solution
  • Drug: Placebo
    Inhalation solution
Study Arms  ICMJE
  • Experimental: BI 1265162
    Intervention: Drug: BI 1265162
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2019)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 9, 2020
Estimated Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients, 12 years of age or older at screening;
  • Documented diagnosis of cystic fibrosis including:

    • positive sweat chloride ≥ 60 mEq/L, by pilocarpine iontophoresis OR
    • genotype with 2 identifiable mutations consistent with cystic fibrosis accompanied by one or more clinical features with cystic fibrosis phenotype;
  • Patients able to perform acceptable spirometric manoeuvres according to American Thoracic Society (ATS) standards;
  • FEV1 ≥ 40% and ≤ 90% of predicted values at screening and predose at Visit 2;
  • Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a failure rate of less than1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient (or patient's legal guardian) information;
  • Signed and dated written informed consent and assent in accordance with ICH Harmonized Guideline for Good Clinical Practice (GCP) and local legislation prior to admission in the trial.

Exclusion Criteria:

  • Evidence of acute upper or lower respiratory tract infection within 4 weeks prior to randomization based on investigator's judgement;
  • Pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics or oral corticosteroids within 4 weeks prior to randomisation;
  • Patients with history of Acute Tubular Necrosis (ATN);
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix;
  • Patients unable to inhale trial drug in an appropriate manner from the Respimat® inhaler based on investigator's judgement;
  • Patients who have started a new chronic medication for CF within 4 weeks of randomisation;
  • Patients who have previously received a lung transplant or patients who are currently on a waiting list to receive a lung transplant;
  • Patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the investigator or with a known hypersensitivity to trial drug or its components. "Significance" in this context refers to any increased risk of hypersensitivity reaction to trial medication;
  • Any clinically significant laboratory abnormalities at screening as judged by the investigator, or any of the following:

    • Potassium > upper limit of normal (ULN) in non-haemolysed blood
    • Abnormal renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60ml/min/1.73m²
    • Abnormal liver function, defined by serum level of either alanine transaminase (ALT), aspartate transaminase (AST) or total bilirubine ≥ 3 x upper limit of normal (ULN)
  • Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the data quality. This includes significant haematological, hepatic, renal, cardiovascular and neurologic disease. Patients with diabetes may participate if their disease is under good control prior to screening;
  • Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled;
  • Previous randomisation in this trial;
  • Currently enrolled in another investigational device or drug trial, or less than 30 days or six half-lives (whichever is greater) since ending another investigational device or drug trial(s), or receiving other investigational treatment(s);
  • Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial;
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059094
Other Study ID Numbers  ICMJE 1399-0003
2019-000261-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://trials.boehringer‐ingelheim.com
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP