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Idiopathic Pulmonary FibrosisPhase 3NCT01979952

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

A Phase 3 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Nintedanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
25 sitesin 3 countries
Study dates
26 Nov 2013to 27 Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 20Show fewer
  • 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
  • Previous treatment with nintedanib within a clinical trial in the previous 3 months and discontinuation of nintedanib study treatment due to an adverse event
  • Known hypersensitivity to the trial drug or its component
  • 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.
  • Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
  • 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.

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States11 sites

  • Lowcountry Lung and Crit Care

    Charleston, South Carolina, 29406

  • Annette C & Harold C Simmons Transplant Institute

    Dallas, Texas, 75246

  • Western CT Medical Group, P.C.

    Danbury, Connecticut, 06810

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Minnesota Lung Research

    Minneapolis, Minnesota, 55407

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Clinical Research Center Sarasota Memorial Hosptial

    Sarasota, Florida, 34239

  • Chest Medicine Clinical Services

    Skokie, Illinois, 60076

  • ID Clinical Research, LTD

    Toledo, Ohio, 43608

Other trials in United States

Canada7 sites

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2G3

  • QEII Health Sciences Centre (Dalhousie University)

    Halifax, Nova Scotia, B3H 3A7

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • CHUS Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Concordia Hospital

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Turkey (Türkiye)7 sites

  • Cukurova Universitesi Tip Fakultesi Gog. Hast. Anabilim Dali

    Adana, 01330

  • Ankara Universitesi Tip Fakultesi

    Ankara, 06100

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Yedikule Gog. Hst. EAH

    Istanbul, 34760

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

    Istanbul, 34844

  • Ege Universitesi T.F.

    Izmir, 35100

  • Dr.Suat Seren EAH

    Izmir, 35110

Other trials in Turkey (Türkiye)

About this study

Official title: A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months

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.

Being tested
Matching Placebo, Nintedanib
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Matching PlaceboDrug

    twice daily dosing

  • NintedanibDrug

    gelating capsule

Study groups in NCT01979952
Study groupRoleWhat they receive
NintedanibExperimental150 mg twice daily
Receives: Drug: Nintedanib
PlaceboPlacebo comparatortwice daily dosing
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 Months

Secondary outcomes (11)

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

    Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable.

    HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment.

    Measured: Baseline and 12 Months

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

    Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.

    Measured: Baseline and 6 Months

  3. Relative Change in FVC From Baseline at 6 Months

    Relative change in FVC from baseline at 6 months is presented.

    Measured: Baseline and 6 Months

  4. Categorical Change in FVC From Baseline at 6 Months

    Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.

    Measured: Baseline and 6 Months

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

    SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.

    The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.

    Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).

    Measured: Baseline and 6 Months

  6. 6MWT Total Distance Walked Change From Baseline at 6 Months

    Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented.

    The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria.

    Measured: Baseline and 6 Months

  7. University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months

    University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).

    Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).

    Measured: Baseline and 6 Months

  8. All-cause Mortality at 6 Months

    Percentage of subjects died from all causes between 0 to 6 months are presented.

    Measured: 6 Months

  9. Respiratory Hospitalizations at 6 Months

    Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.

    Measured: 6 Months

  10. Respiratory Mortality at 6 Months

    Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.

    Measured: 6 Months

  11. Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months

    Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study start26 Nov 2013
  3. Primary completion27 Oct 2016
  4. Study completion27 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01979952
Sponsor's protocol ID
1199.187
Status last verified
Mar 2018
First submitted
4 Nov 2013
Last updated
17 Apr 2018

Publications

  • 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.

    PubMed 33902584

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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