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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

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ClinicalTrials.gov Identifier: NCT04059094
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: BI 1265162 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 2, 2020
Estimated Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 1265162 Drug: BI 1265162
Inhalation solution
Placebo Comparator: Placebo Drug: Placebo
Inhalation solution


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from baseline in Lung Clearance Index (LCI) assessed by N2 Multiple Breath Washout (N2MBW) procedure [ Time Frame: Up to 4 weeks ]
  2. Change from baseline in Cystic Fibrosis Questionnaire Revised (CFQ-R) total score [ Time Frame: Up to 4 weeks ]
  3. Change from baseline in Cough and Sputum Assessment Questionnaire (CASA-Q) (4 separate sub-scores) [ Time Frame: Up to 4 weeks ]
  4. Percentage of patients with treatment-emergent Adverse Events (AE) [ Time Frame: Up to day 36 ]
  5. Ct,N (concentration of the analyte in plasma at time t following dose N) [ Time Frame: Up to day 36 ]
  6. Cpre,N (predose concentration measured for dose N) [ Time Frame: Up to day 29 ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059094


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Florida
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Shatha Yousef    +001 (407) 650-7000    shatha.yousef@nemours.org   
United States, Indiana
Riley Hospital for Children at Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Clement Ren    +001 (317)-948-7180    clren@iu.edu   
Belgium
Brussels - UNIV UZ Brussel Recruiting
Brussels, Belgium, 1090
Contact: Elke De Wachter    +32(0)24 77.57.65    elke.dewachter@uzbrussel.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Marijke Proesmans    +32 16 34 38 40    marijke.proesmans@uzleuven.be   
France
HOP Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Philippe Reix    +33 (0)4 27 85 54 70    philippe.reix@chu-lyon.fr   
HOP Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Raphaël Chiron    +33 (0)4 67 33 60 89    r-chiron@chu-montpellier.fr   
HOP Necker Recruiting
Paris, France, 75015
Contact: Isabelle Sermet-Gaudelus    +33 (0)1 44 49 48 87    isabelle.sermet@aphp.fr   
HOP Robert Debré Recruiting
Paris, France, 75019
Contact: Bertrand Delaisi    +33 (0)1 40 03 53 92    bertrand.delaisi@aphp.fr   
HOP Cochin Recruiting
Paris, France, 75679
Contact: Isabelle Fajac    +33 (0)1 58 41 30 65    isabelle.fajac@parisdescartes.fr   
HOP Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Isabelle Durieu    +33 (0)4 78 56 90 49    isabelle.durieu@chu-lyon.fr   
HOP Perharidy Recruiting
Roscoff, France, 29684
Contact: Anne Dirou-Prigent    +33 (0)2 98 29 39 39    anne.dirou@ildys.org   
HOP Paule de Viguier Recruiting
Toulouse, France, 31059
Contact: Marie Mittaine    +33 (0)5 67 77 13 14    mittaine.m@chu-toulouse.fr   
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Marcus Mall    +49 (30) 450566131    marcus.mall@charite.de   
Universitätsklinikum Gießen und Marburg GmbH Recruiting
Gießen, Germany, 35385
Contact: Lutz Nährlich    +49 (641) 985 57621    lutz.naehrlich@paediat.med.uni-giessen.de   
Sweden
Sahlgrenska US, Göteborg Recruiting
Göteborg, Sweden, 413 45
Contact: Marita Gilljam    0046313428120    marita.gilljam@lungall.gu.se   
Stockholm CF-Center , B59, Huddinge Universitetssjukhus Recruiting
Stockholm, Sweden, 141 86
Contact: Lena Hjelte    0046858587359    lena.hjelte@sll.se   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04059094     History of Changes
Other Study ID Numbers: 1399-0003
2019-000261-21 ( EudraCT Number )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases