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Nintedanib for Idiopathic Pulmonary Fibrosis
Phase 2
Waitlist Available
Led By Jonathan A Galli, MD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults between the ages of 35-70.
Lung transplantation listing diagnosis of pulmonary fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
Study Summary
This study is evaluating whether a drug may help improve lung function for individuals who have had a lung transplant.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
- Lung Transplant Complications
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FEV1
Change in FVC
Secondary outcome measures
Acute cellular rejection
Adverse drug events
Bronchial dehiscence
+14 moreSide effects data
From 2017 Phase 4 trial • 105 Patients • NCT0257960331%
Diarrhoea
16%
Dyspnoea
12%
Nausea
12%
Vomiting
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Dizziness
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Gastrooesophageal reflux disease
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NintedanibExperimental Treatment1 Intervention
Nintedanib 150 mg tablet by mouth twice daily for 24 months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet by mouth twice daily for 24 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
FDA approved
Find a Location
Who is running the clinical trial?
Temple UniversityLead Sponsor
294 Previous Clinical Trials
81,797 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
3,611 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Boehringer IngelheimIndustry Sponsor
2,494 Previous Clinical Trials
10,916,871 Total Patients Enrolled
47 Trials studying Idiopathic Pulmonary Fibrosis
44,552 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Jonathan A Galli, MDPrincipal InvestigatorTemple University
Frequently Asked Questions
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