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

NCT01979952 | Completed Phase 3 Results

• 1 other identifier: 1199.187
• Study Type: interventional
• Target: 113
• Locations: 3 countries
• Sites: 25

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

Outcome Measures

Primary Outcomes (1)

• Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months

  Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.

  Baseline and 6 Months

Secondary Outcomes (11)

• Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months

  Baseline and 12 Months

• Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months

  Baseline and 6 Months

• Relative Change in FVC From Baseline at 6 Months

  Baseline and 6 Months

• Categorical Change in FVC From Baseline at 6 Months

  Baseline and 6 Months

• St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months

  Baseline and 6 Months

Study Arms (2)

Nintedanib

EXPERIMENTAL

150 mg twice daily

Drug: Nintedanib

Placebo

PLACEBO COMPARATOR

twice daily dosing

Drug: Matching Placebo

Interventions

Matching Placebo DRUG

twice daily dosing

Placebo

Nintedanib DRUG

gelating capsule

Nintedanib

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent consistent with International Conference on Harmonisation Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study
• Patient aged \>= 40 years at Visit 1.
• 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.
• Carbon monoxide Diffusing capacity or Transfer factor of the lung for carbon monoxide (DLCO) (corrected for Hb): 30%-79% predicted of normal
• Forced Vital Capacity (FVC) \>= 50% predicted of normal at Visit 1 and Visit 2

You may not qualify if:

• AST, ALT \> 1.5 fold ULN
• Bilirubin \> 1.5 fold ULN
• Bleeding risk:
• 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)
• History of hemorrhagic Central Nervous System (CNS) event within 12 months
• Any of the following within 3 months:
• Haemoptysis or haematuria.
• Active gastro-intestinal bleeding or ulcers.
• Major injury or surgery.
• Coagulation parameters: International normalised ratio (INR) \> 2, prothrombin time (PT) and partial thromboplastin time (PTT) \> 150% of institutional ULN.
• Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
• Thrombotic risk
• Known inherited predisposition to thrombosis.
• History of thrombotic event (including stroke and transient ischemic attacks) within 12 months
• Current or planned usage of any investigational drug during the course of this trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (25)

Western CT Medical Group, P.C.

Danbury, Connecticut, 06810, United States

Location

Clinical Research Center Sarasota Memorial Hosptial

Sarasota, Florida, 34239, United States

Location

Chest Medicine Clinical Services

Skokie, Illinois, 60076, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Minnesota Lung Research

Minneapolis, Minnesota, 55407, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

ID Clinical Research, LTD

Toledo, Ohio, 43608, United States

Location

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

Lowcountry Lung and Crit Care

Charleston, South Carolina, 29406, United States

Location

Annette C & Harold C Simmons Transplant Institute

Dallas, Texas, 75246, United States

Location

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, T6G 2G3, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

QEII Health Sciences Centre (Dalhousie University)

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Cukurova Universitesi Tip Fakultesi Gog. Hast. Anabilim Dali

Adana, 01330, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Yedikule Gog. Hst. EAH

Istanbul, 34760, Turkey (Türkiye)

Location

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

Istanbul, 34844, Turkey (Türkiye)

Location

Ege Universitesi T.F.

Izmir, 35100, Turkey (Türkiye)

Location

Dr.Suat Seren EAH

Izmir, 35110, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33902584 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This study was an exploratory trial that was not statistically powered to demonstrate significant differences between treatment groups for the efficacy endpoints evaluated.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: November 26, 2013
• Primary Completion: October 27, 2016
• Study Completion: October 27, 2016
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

CA (7); TU (7); US (11)