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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01335477




Registration number
NCT01335477
Ethics application status
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
25/07/2016

Titles & IDs
Public title
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
Scientific title
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2010-024252-29
Secondary ID [2] 0 0
1199.34
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Advanced Cancer 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - BIBF 1120

Placebo comparator: placebo - patient receives capsules identical to those containing active drug

Experimental: BIBF 1120 - patient receives capsules containing BIBF 1120 twice a day

Experimental: Non-comparative, open-label Nabiximols - Nabiximols was self-administered by participants as a 100 microliter (µL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 µL actuation delivered 2.7 mg THC and 2.5 mg CBD.


Treatment: Drugs: placebo
placebo matching BIBF 1120 BID

Treatment: Drugs: BIBF 1120
BIBF 1120 BID (twice daily)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.
Timepoint [1] 0 0
52 weeks
Primary outcome [2] 0 0
Percent Of Participants With Treatment-emergent Adverse Events
Timepoint [2] 0 0
Baseline, Day 183
Secondary outcome [1] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
Timepoint [1] 0 0
Baseline and 52 weeks
Secondary outcome [2] 0 0
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [3] 0 0
Baseline and 52 weeks
Secondary outcome [4] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [4] 0 0
Baseline and 52 weeks
Secondary outcome [5] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [5] 0 0
Baseline and 52 weeks
Secondary outcome [6] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [6] 0 0
Baseline and 52 weeks
Secondary outcome [7] 0 0
Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold
Timepoint [7] 0 0
Baseline and 52 weeks
Secondary outcome [8] 0 0
Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold
Timepoint [8] 0 0
Baseline and 52 weeks
Secondary outcome [9] 0 0
FVC Responders Using 10% Threshold at 52 Weeks
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
Proportion of FVC Responders Using 5% Threshold at 52 Weeks
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [11] 0 0
baseline and 52 weeks
Secondary outcome [12] 0 0
Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [12] 0 0
baseline and 52 weeks
Secondary outcome [13] 0 0
Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [13] 0 0
baseline and 52 weeks
Secondary outcome [14] 0 0
Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [14] 0 0
baseline and 52 weeks
Secondary outcome [15] 0 0
Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [15] 0 0
baseline and 52 weeks
Secondary outcome [16] 0 0
Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [16] 0 0
baseline and 52 weeks
Secondary outcome [17] 0 0
Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [17] 0 0
baseline and 52 weeks
Secondary outcome [18] 0 0
Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [18] 0 0
baseline and 52 weeks
Secondary outcome [19] 0 0
Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [19] 0 0
52 weeks
Secondary outcome [20] 0 0
Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)
Timepoint [20] 0 0
baseline, 12 weeks, 24 weeks and 52 weeks
Secondary outcome [21] 0 0
Risk of an Acute IPF Exacerbation Over 52 Weeks
Timepoint [21] 0 0
52 weeks
Secondary outcome [22] 0 0
Time to Death Over 52 Weeks
Timepoint [22] 0 0
52 weeks
Secondary outcome [23] 0 0
Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)
Timepoint [23] 0 0
52 weeks
Secondary outcome [24] 0 0
Time to On-treatment Death
Timepoint [24] 0 0
52 weeks
Secondary outcome [25] 0 0
Time to Death or Lung Transplant Over 52 Weeks
Timepoint [25] 0 0
52 weeks
Secondary outcome [26] 0 0
Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.
Timepoint [26] 0 0
52 weeks
Secondary outcome [27] 0 0
Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks
Timepoint [27] 0 0
baseline and 52 weeks
Secondary outcome [28] 0 0
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks
Timepoint [28] 0 0
baseline and 52 weeks
Secondary outcome [29] 0 0
Change From Baseline In Mean NRS Average Pain During The Last Period
Timepoint [29] 0 0
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Secondary outcome [30] 0 0
Change From Baseline In Mean Sleep Disruption NRS During The Last Period
Timepoint [30] 0 0
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Secondary outcome [31] 0 0
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Timepoint [31] 0 0
Last Visit (up to Day 183)
Secondary outcome [32] 0 0
Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
Timepoint [32] 0 0
Baseline, Last Visit (up to Day 183)

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC>= 50% predicted of normal
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago de Chile
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Shenyang
Country [29] 0 0
China
State/province [29] 0 0
Yinchuan
Country [30] 0 0
Finland
State/province [30] 0 0
Helsinki
Country [31] 0 0
France
State/province [31] 0 0
Dijon Cedex
Country [32] 0 0
France
State/province [32] 0 0
Lille Cedex
Country [33] 0 0
France
State/province [33] 0 0
Lyon Cedex
Country [34] 0 0
France
State/province [34] 0 0
Marseille
Country [35] 0 0
France
State/province [35] 0 0
Montpellier cedex 5
Country [36] 0 0
France
State/province [36] 0 0
Toulouse cedex 9
Country [37] 0 0
Germany
State/province [37] 0 0
Bad Berka
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin-Buch
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Coswig
Country [41] 0 0
Germany
State/province [41] 0 0
Essen
Country [42] 0 0
Germany
State/province [42] 0 0
Greifswald
Country [43] 0 0
Germany
State/province [43] 0 0
Immenhausen
Country [44] 0 0
Germany
State/province [44] 0 0
Köln
Country [45] 0 0
Germany
State/province [45] 0 0
München
Country [46] 0 0
Germany
State/province [46] 0 0
Münster
Country [47] 0 0
Greece
State/province [47] 0 0
Athens
Country [48] 0 0
Greece
State/province [48] 0 0
Heraklion
Country [49] 0 0
Greece
State/province [49] 0 0
Larisa
Country [50] 0 0
Greece
State/province [50] 0 0
Maroussi, Athens
Country [51] 0 0
Greece
State/province [51] 0 0
Nikaia
Country [52] 0 0
India
State/province [52] 0 0
Ahmedabad
Country [53] 0 0
India
State/province [53] 0 0
Banglore
Country [54] 0 0
India
State/province [54] 0 0
Jaipur
Country [55] 0 0
India
State/province [55] 0 0
Pune
Country [56] 0 0
Japan
State/province [56] 0 0
Himeji, Hyogo
Country [57] 0 0
Japan
State/province [57] 0 0
Kawasaki, Kanagawa
Country [58] 0 0
Japan
State/province [58] 0 0
Kobe, Hyogo
Country [59] 0 0
Japan
State/province [59] 0 0
Minato-ku, Tokyo
Country [60] 0 0
Japan
State/province [60] 0 0
Nagoya, Aichi
Country [61] 0 0
Japan
State/province [61] 0 0
Ogaki, Gifu
Country [62] 0 0
Japan
State/province [62] 0 0
Osaka-Sayama, Osaka
Country [63] 0 0
Japan
State/province [63] 0 0
Sakai, Osaka
Country [64] 0 0
Japan
State/province [64] 0 0
Seto, Aichi
Country [65] 0 0
Japan
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Shinjuku-ku, Tokyo
Country [66] 0 0
Japan
State/province [66] 0 0
Tenri, Nara
Country [67] 0 0
Japan
State/province [67] 0 0
Tokushima, Tokushima
Country [68] 0 0
Japan
State/province [68] 0 0
Yonago, Tottori
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Bucheon
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Incheon
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Mexico
State/province [72] 0 0
Mexico DF
Country [73] 0 0
Netherlands
State/province [73] 0 0
Amsterdam
Country [74] 0 0
Netherlands
State/province [74] 0 0
Nieuwegein
Country [75] 0 0
Netherlands
State/province [75] 0 0
Rotterdam
Country [76] 0 0
Portugal
State/province [76] 0 0
Amadora
Country [77] 0 0
Portugal
State/province [77] 0 0
Coimbra
Country [78] 0 0
Portugal
State/province [78] 0 0
Lisboa
Country [79] 0 0
Portugal
State/province [79] 0 0
Porto
Country [80] 0 0
Portugal
State/province [80] 0 0
Vila Nova de Gaia
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Kazan
Country [82] 0 0
Russian Federation
State/province [82] 0 0
St. Petersburg
Country [83] 0 0
Spain
State/province [83] 0 0
Barcelona
Country [84] 0 0
Spain
State/province [84] 0 0
Hospitalet de Llobregat
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Istanbul
Country [89] 0 0
Turkey
State/province [89] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01335477