Nintedanib for Pneumonia, Interstitial

Phase-Based Estimates
2
Effectiveness
3
Safety
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa, Warszawa, Poland
Pneumonia, Interstitial+1 More
Nintedanib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Pneumonia, Interstitial

Study Summary

This study is evaluating whether a drug called nintedanib is safe and tolerable for people with idiopathic pulmonary fibrosis.

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Eligible Conditions

  • Pneumonia, Interstitial
  • Lung Diseases, Interstitial
  • Lung Diseases

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Nintedanib will improve 1 primary outcome in patients with Pneumonia, Interstitial. Measurement will happen over the course of Up to 36 months.

Up to 36 months
Incidence of overall adverse events over the course of this extension trial

Trial Safety

Side Effects for

Nintedanib + Pirfenidone
Nausea
42%
Diarrhoea
38%
Vomiting
28%
Fatigue
19%
Abdominal pain upper
13%
Headache
13%
Decreased appetite
11%
Bronchitis
9%
Nasopharyngitis
8%
Abdominal pain
8%
Cough
8%
Abdominal discomfort
8%
Weight decreased
8%
Pyrexia
6%
Dysgeusia
6%
Hepatocellular injury
6%
Alanine aminotransferase increased
6%
Constipation
6%
Gamma-glutamyltransferase increased
6%
Photosensitivity reaction
6%
Gastrooesophageal reflux disease
6%
Aspartate aminotransferase increased
6%
Dyspnoea
4%
Asthenia
2%
Pneumonia
2%
Idiopathic pulmonary fibrosis
2%
Circulatory collapse
2%
Phlebitis
0%
Transient ischaemic attack
0%
Pancreatitis acute
0%
Acute respiratory failure
0%
Dizziness
0%
Contusion
0%
Atrial flutter
0%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02579603) in the Nintedanib + Pirfenidone ARM group. Side effects include: Nausea with 42%, Diarrhoea with 38%, Vomiting with 28%, Fatigue with 19%, Abdominal pain upper with 13%.

Trial Design

2 Treatment Groups

Control
All subjects

This trial requires 436 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nintedanib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

All subjects
Drug
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Closest Location

Baylor University Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
leaflet In order to protect themselves from pregnancy, women of childbearing potential who take nintedanib must use a highly effective birth control method with a low failure rate of less than 1% per year, as well as one barrier method, for 28 days before and three months after taking the medication show original
Before registering for the study, volunteers must sign a written form stating that they understand the risks and benefits of participating and are willing to let the researchers use their data show original
Male or female patients who completed the INBUILD trial as planned and did not prematurely discontinue their treatment. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes pneumonia, interstitial?

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This paper provides a brief review of the causes of interstitial pneumonia, which may include lung infections (e.g., pneumonia), lung inflammatory and immune responses (e.g. post-infection sequelae or autoimmune disorders), and other lung inflammatory or immune responses (e.g. hypersensitivity responses).

Unverified Answer

What are the signs of pneumonia, interstitial?

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Pneumonia, interstitial may have many possible symptoms: an acute onset cough with increased volume and a rapid rate, wheezing and crack/rhoneness, chest pain and pain behind the sternum, fever, sweating, shortness of breath, feeling low, and rapid weight loss. One-fifth of people hospitalized with pneumonia, interstitial may in fact have a lung infection (such as staphylococcal pneumonia).\n

Unverified Answer

Can pneumonia, interstitial be cured?

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Pneumonia, interstitial can be treated by using Power’s ‘Pneumonia and Interstitial Clinical Trials’ link. They can help you find available clinical trials near you. [Power’s] ‘Pneumonia and Interstitial’ link: [Power’s] ‘Pneumonia and Interstitial’ link: http://clinic2.info/index.

Unverified Answer

Does pneumonia, interstitial run in families?

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This large family study has demonstrated that the occurrence of ILD in family members with PIB is greater than previously known. The family frequency of ILD-PIB has a strong genetic basis, but is in close agreement with the previously published frequency of bronchiectasis in the general population. It is likely that the association of ILD and PIB represents a common genetic linkage with a modifier effect for bronchiectasis.

Unverified Answer

Has nintedanib proven to be more effective than a placebo?

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The present data support further investigation of the effectiveness of nintedanib in the treatment of patients with unresectable or metastatic lung cancer with wild-type K-Ras. At present, the role of nintedanib is not clearly defined in this patient group.

Unverified Answer

What is the average age someone gets pneumonia, interstitial?

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The median age of people who get pneumonia, interstitial is 54.0 years. More than 90% of people who get pneumonia, interstitial is 50 years or older. This compares to 60.2% for people who get asthma and 48.1% for people who get heart failure. It is easier to prevent pneumonia, interstitial and heart failure when babies, kids and the elderly stay healthy.

Unverified Answer

What are common treatments for pneumonia, interstitial?

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There are several kinds of drug used in the treatment of pneumonia. The most popular agents include fluoroquinolones and aminopenicillins, along with macrolides and fluoroquinolones. There are many medications used to treat interstitial pneumonia, such as prednisone and azathioprine, along with corticosteroids.\n

Unverified Answer

What is pneumonia, interstitial?

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The term “pneumonia, interstitial,” a diagnosis given in acute presentation (i.e., presenting with acute symptoms of respiratory illness and suggestive radiographic appearance), is no longer recommended. A more specific term for presentation with acute symptoms and suggestive radiographic appearance – community acquired pneumonia, not associated with acute onset symptoms – is advised. To specify severity of pneumonia when presenting with acute symptoms (i.e., presenting with acute symptoms suggestive of pneumonia) is no longer supported.

Unverified Answer

How many people get pneumonia, interstitial a year in the United States?

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Nearly one half million US adults are hospitalized each year with pneumonia, and 800,000-1,000,000 of these patients are hospitalized with pneumonia, interstitial pneumonia, or acute respiratory distress syndrome. Pneumonia, interstitial pneumonia, and acute respiratory distress syndrome are common, disabling, and potentially deadly conditions. While most hospitalized patients with pneumonia, interstitial pneumonia, or acute respiratory distress syndrome die within the hospital, some survive to discharged from the hospital while others die from complications associated with their underlying disease during hospitalization.

Unverified Answer

Who should consider clinical trials for pneumonia, interstitial?

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Clinical trials have not been widely accepted as a source for research for community health providers and clinicians. Physicians have not been taught or given guidance when to apply for research funding, and therefore little research goes into community practice. The lack of awareness among clinicians and healthcare providers impedes the delivery of proven interventions through standard practice and prevents communities from engaging in research. The need to develop effective and efficient clinical trials in community practice is likely to require the involvement of primary healthcare practitioners and healthcare systems such as the VA Medical Center in Northern Taiwan.

Unverified Answer

Have there been any new discoveries for treating pneumonia, interstitial?

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Patients admitted to the hospital with non-diagnosed pneumonia may not have pneumonia, rather infections of respiratory tract caused by [Streptococcus pneumoniae]. This is an alarming problem as infections may result in septic shock and death. Currently [patients are given] antibiotics against infections. There are no treatments, vaccines or therapeutic agents for pneumonia. It is crucial to develop diagnostic tools to help clinicians correctly diagnose pneumonia and avoid unnecessary antibiotic treatment.

Unverified Answer

Does nintedanib improve quality of life for those with pneumonia, interstitial?

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Treatment with nintedanib is associated with improvements in lung function and HR-QoL in patients with PDL, with improvements also reported by survivors of PDL. Nintedanib therapy has been associated with improvements in HR-QoL and symptoms for patients with PIV compared with matched PIV in the absence of treatment. Further research into long-term HR-QoL in survivors is required to fully evaluate the impact of treatment with nintedanib on life expectancy.

Unverified Answer
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