Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT01979952

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-26
• Study Completion Date: 2016-10-27

Brief Summary

This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nintedanib

150 mg twice daily

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

gelating capsule

Placebo

twice daily dosing

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

twice daily dosing

Interventions

Matching Placebo

twice daily dosing

Intervention Type: DRUG

Nintedanib

gelating capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written Informed Consent consistent with International Conference on Harmonisation Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study

2. Patient aged >= 40 years at Visit 1.

3. IPF diagnosed, according to the 2011 American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society(JRS)/ Latin American Thoracic Association (ALAT)/ Latin American Thoracic Association/ Idiopathic Pulmonary Fibrosis (IPF) guidelines for diagnosis and management, within 5 years and reaffirmed applying 2011 Guidelines (P11-07084) if diagnosed >2 years and up to 5 year from Visit 1,. Diagnosis must be confirmed by chest High Resolution Computerized Tomography (HRCT) taken within 24 months of Visit 1. All HRCT results reported to be possible or inconsistent usual interstitial pneumonia (UIP) must have confirmatory pathology.

4. Carbon monoxide Diffusing capacity or Transfer factor of the lung for carbon monoxide (DLCO) (corrected for Hb): 30%-79% predicted of normal

5. Forced Vital Capacity (FVC) >= 50% predicted of normal at Visit 1 and Visit 2

Exclusion Criteria

1. AST, ALT > 1.5 fold ULN

2. Bilirubin > 1.5 fold ULN

3. Bleeding risk:

1. Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin), or high dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy)

2. History of hemorrhagic Central Nervous System (CNS) event within 12 months

3. Any of the following within 3 months:

• Haemoptysis or haematuria.
• Active gastro-intestinal bleeding or ulcers.
• Major injury or surgery.

4. Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN.

4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.

5. Thrombotic risk

1. Known inherited predisposition to thrombosis.

2. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months

6. Current or planned usage of any investigational drug during the course of this trial

7. Previous treatment with nintedanib within a clinical trial in the previous 3 months and discontinuation of nintedanib study treatment due to an adverse event

8. Known hypersensitivity to the trial drug or its component

9. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patient's ability to participate in this trial. Patients will be excluded if they require greater than 12L/min oxygen, are not ambulatory or require use of a walker or cane during the 6 Minute Titration Walk Test. Patients who cannot complete the 6 Minute Titration Walk Test are excluded from participation.

10. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.

11. Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or not committing to using it until 3 months after end of treatment.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Western CT Medical Group, P.C.

Danbury, Connecticut, United States

Clinical Research Center Sarasota Memorial Hosptial

Sarasota, Florida, United States

Chest Medicine Clinical Services

Skokie, Illinois, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Minnesota Lung Research

Minneapolis, Minnesota, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Winthrop University Hospital

Mineola, New York, United States

ID Clinical Research, LTD

Toledo, Ohio, United States

The Oregon Clinic

Portland, Oregon, United States

Lowcountry Lung and Crit Care

Charleston, South Carolina, United States

Annette C & Harold C Simmons Transplant Institute

Dallas, Texas, United States

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Concordia Hospital

Winnipeg, Manitoba, Canada

QEII Health Sciences Centre (Dalhousie University)

Halifax, Nova Scotia, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

CHUS Fleurimont

Sherbrooke, Quebec, Canada

Cukurova Universitesi Tip Fakultesi Gog. Hast. Anabilim Dali

Adana, , Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Yedikule Gog. Hst. EAH

Istanbul, , Turkey (Türkiye)

Sureyyapasa Gogus Hast. ve Gogus Cer. Egit. ve Aras. Has.

Istanbul, , Turkey (Türkiye)

Ege Universitesi T.F.

Izmir, , Turkey (Türkiye)

Dr.Suat Seren EAH

Izmir, , Turkey (Türkiye)

Countries

United States; Canada; Turkey (Türkiye)

References

Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

Reference Type: DERIVED

PMID: 33902584 (View on PubMed)

Other Identifiers

1199.187

Identifier Type: -

Identifier Source: org_study_id