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FDA Workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial (NTM) Disease

Posted on April 17, 2019   |   
Author: Gretchen   |   
3 Comments   |   
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This blog post was written by Gretchen McCreary, Research Coordinator, COPD Foundation

The Food and Drug Administration (FDA) held a successful workshop on April 8, 2019 entitled, Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial (NTM) Disease. The workshop panelists included experts in their fields of NTM and Patient-Reported Outcomes (PROs). The goal of the workshop was to discuss clinical trial design related to the advancement of antibacterial therapies to treat NTM. Among the topics discussed, the panelists presented on and delved into the patient perspective for treatment of NTM, lessons learned from completed NTM trials and the implications for future trials, use of patient-reported outcome measures in NTM trials, as well as academic and industry perspectives on various case studies.

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Categories: Awareness Research

Research 101 Webinar

Posted on March 26, 2019   |   
Author: Gretchen   |   
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We hope you were able to join us for our March 2019 Research 101 webinar. We are pleased to offer you the full recording from this event here. The recording is free and can be accessed at any time.

During the 50-minute webinar, Dr. Yawn and Dr. Mularski gave an overview of research, the different types of research, questions to ask before participating in research, as well as a breakdown of clinical terms and “big words” associated with various types of studies. They were joined by Pam DeNardo, a patient partner, who discussed her experience with research along with her participation in the COPD Patient-Powered Research Network.

More about your expert speakers

Dr. Barbara Yawn, MD, MSc Dr. Barbara Yawn, MD, MSc is a long-time clinical researcher studying how to improve respiratory care in rural and primary care settings. She is currently the Chief Science Officer of the COPD Foundation and co-PI of the COPD Patient Powered Research Network.

Dr. Mularski, MD, MSHS, MCR Dr. Mularski, MD, MSHS, MCR, leads health services research in the areas of obstructive lung disease, palliative care, and delivery science at the Kaiser Permanente Center for Health Research in Portland Oregon; he is also a Clinical Professor of Medicine and Senior Scholar of Ethics at Oregon Health & Science University. He practices pulmonary and critical care medicine as a Senior Physician for Northwest Permanente where he also serves as Regional Clinical Quality Lead for COPD and is the Director of Research and Evaluation for the northwest KP region. He is a founding steering committee member of CONCERT and co-PI of the COPD Patient Powered Research Network.

Pam DeNardo Pam DeNardo is a COPD patient of 20 years and an advocate with the COPD Foundation in many positions since its inception. Along with Bill Clark and John Walsh, she started the COPD Foundation's Information Line in 2007. And like many here, she is a firm believer in the importance of research but also its misunderstandings among the patient population.


The COPD Foundation would like to thank Dr. Yawn, Dr. Mularski and Pam DeNardo for their participation in the Research 101 webinar. Stay tuned for information on upcoming events!

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Tags: COPD PPRN COPD Registries Research 101 Research Awareness
Categories: Research

MAC Patient Advisor for Study Advisory Panel

Posted on January 17, 2019   |   
Author: Gretchen   |   
1 Comments   |   
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We are looking for 1 additional (male) pulmonary MAC patient advisor for Kevin Winthrop’s PCORI-funded MAC2v3 pragmatic trial!

This is a remote advisor position, no travel for in-person meetings. Note that while this is a 5-year project, a full 5-year commitment to participate is not required. We have 4 patient advisors already identified, and are looking for 1 more to round out the panel.

This study is titled Comparison of two- versus three-antibiotic therapy for pulmonary Mycobacterium avium complex disease (“MAC2v3”). We will prospectively follow patients newly diagnosed with NTM who are randomized to either a 2-drug or 3-drug treatment regimen. Our objective is to determine whether or not a 2-drug treatment regimen is better tolerated and as effective (based on culture analysis) as a 3-drug regimen.

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Tags: MAC NTM NTM Research Patient Advisor
Categories: Research

Physician Update on Respiratory Disease Treatment: Inhaled Corticosteroids vs. Oral Antibiotics

Posted on September 12, 2018   |   
Author: Gretchen   |   
2 Comments   |   
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This blog post was written by Beth McKnight, Patient Advocate, with the help of a Patient Advisory Panel.

Researchers at Oregon Health and Science University have found that long-term treatment of respiratory diseases with inhaled corticosteroid drugs actually increases the risk of serious lung infections.

The study, presented at the 2018 American Thoracic Society International Conference, focused on adult patients with bronchiectasis, whose bronchial tubes are thickened from inflammation and infection, preventing the clearing of mucus. Bronchiectasis, most accurately diagnosed by a CT scan, is on the rise in the U.S.

Dr. Emily Henkle, presenting author, said the team found that inhaled corticosteroid use increased the risk of hospitalized infections, and no evidence exists that they prevent exacerbations or progression of the disease. The study examined Medicare data from 90,000 patients who used either inhaled corticosteroids or the oral antibiotics azithromycin and erythromycin. The study found an increased 39% risk in the corticosteroid group as compared the group taking the oral antibiotics.

However, Dr. Henkle cautioned, potential risks exists with taking just one antibiotic long-term, such as the development of antibiotic resistant bacterial lung diseases like Mycobacterium aviumcomplex (MAC or MAI) and other nontuberculous mycobacterial infections.

What does this mean for physicians who treat patients with bronchiectasis and other lung diseases?

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Tags: Bronchiectasis Bronchiectasis Treatment inhaled corticosteroid drugs MAC oral antibiotics
Categories: Research

World Bronchiectasis Conference 2018-Patient Session Recordings

Posted on August 27, 2018   |   
Author: Gretchen   |   
1 Comments   |   
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Chronic illness affects every aspect of a patient’s life. Research and new therapies are essential to improve the health and well being of those affected with chronic illnesses.

Georgetown University and MedStar Health recently held patient sessions at the World Bronchiectasis Conference this past July. Experts in the field were brought together to discuss the newest research focusing on bronchiectasis and nontuberculous mycobacterial lung infections.

If you were unable to attend, we now have the recordings available from the 6 sessions geared toward patients.

Topics Include

  • Finding physician expertise in my community
  • Pulmonary and ID interaction
  • Nutrition
  • Dealing with the laboratory
  • Obtaining appropriate medications

If you were able to join, please let us know what you found most valuable as a patient or what you wished to have learned more about. You can post your responses on BRONCHANDNTM360SOCIAL or email us at INFO@BRONCHIECTASISANDNTMINITIATIVE.ORG.

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Tags: Basics of Bronchiectasis Bronchiectasis Bronchiectasis Treatment Bronchiectasis; NTM; Research NTM Research World Bronchiectasis Conference 2018
Categories: Research

Moving Closer to an Approved Therapy for NTM Lung Disease: FDA Advisory Committee says Arikayce (Inhaled Liposomal Amikacin) is a safe and effective treatment for those with limited options

Posted on August 08, 2018   |   
Author: Gretchen   |   
6 Comments   |   
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As you know currently there are no FDA-approved treatments specifically for nontuberculous mycobacterial (NTM) lung disease caused by MAC. Yesterday, the Antimicrobial Drugs Advisory Committee of the U.S. Food & Drug Administration met to assess a newly proposed treatment, Arikayce (Inhaled Liposomal Amikacin) for NTM lung disease caused by Mycobacterium avium complex (MAC).

During the meeting, the Advisory Committee heard presentations from Insmed, the company who developed the treatment, the FDA staff who reviews and analyzes data from the treatment’s clinical trials and from the public. Remarkably, 12 community members traveled to the FDA to tell their stories, each having been allotted 5 minutes during the open public hearing session. The physicians, patients, family members and representatives from the COPD Foundation and our partner, NTMir, spoke of the urgent need for new treatment options that are more effective and less toxic. They explained how NTM has changed their life and what it meant to them to have a better chance at achieving culture conversion, the main benefit of the proposed new treatment.

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Tags: Arikayce FDA Inhaled Liposomal Amikacin Inhaled Therapies NTM
Categories: Research

Upcoming FDA Advisory Committee Meeting for ALIS

Posted on July 12, 2018   |   
Author: Gretchen   |   
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The U.S. Food & Drug Administration (FDA) has posted a Federal Register Notice announcing the upcoming Anti-Microbial Advisory Committee Meeting for Insmed’s inhaled liposomal amikacin. The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.

The meeting will take place on August 7, 2018 in the Great Room at the FDA’s White Oak campus (10903 New Hampshire Avenue, Silver Spring, MD).

If you are a patient with MAC lung disease who either did or did not participate in the Insmed clinical trial, and you wish to address the committee during the Open Public Hearing session of the meeting that day, please contact Amy or Susan at ntmmail@ntminfo.org. Please note that the deadline to register as a speaker for the FDA meeting is July 16th, so anyone who is interested should contact them as soon as possible. Compensation will be offered for travel expenses.

It would be most helpful to have two or three patients speak before the committee for 3 to 5 minutes each, addressing the severe unmet need you have as a patient, and how this drug can benefit you. If you participated in the trial, you should also discuss how it helped you, and how it would be beneficial to you to have this drug approved so they can take it.

For those unable to attend the meeting in person or who will not be speaking at the meeting, the FDA offers the opportunity to submit written comments to the docket, no later than July 24, 2018. Statements submitted are public; those submitted before the deadline are printed out and given to committee members with their briefing materials. Comments can be submitted via this link: https://www.regulations.gov/document?D=FDA-2018-N-2490-0001. Just click on the Comment Now! button.

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Tags: FDA Insmed NTM
Categories: Research

Join the FDA Public Workshop on Inhaled Therapies for Bronchiectasis

Posted on June 06, 2018   |   
Author: Gretchen   |   
1 Comments   |   
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The Food and Drug Administration is holding a public workshop entitled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis” on Wednesday, June 27th from 8:30pm to 4:30pm ET.

The purpose of the public workshop is to discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF bronchiectasis.

Why tune in? Currently, there are no treatments that the FDA has approved specifically for bronchiectasis. This workshop will help to provide a better pathway forward to developing new treatments for CF and non-CF bronchiectasis patients, including a discussion about what outcomes are the best to measure, how long trails should be, and how resistance issues should be handled.

Make your voice heard! Did you know that the FDA also considers information provided by patients when making decisions about how new devices and treatments are developed and approved? Are you a patient with Non-Cystic Fibrosis Bronchiectasis? You can register to speak at this public hearing and provide the patient perspective on your experiences with the disease, how symptoms have impacted your daily life, and what outcomes matter most to you. You are the expert, and speakers at the workshop and staff at the FDA are seeking your help and guidance in future clinical trial designs and inhaled antibacterial products. To sign up to speak or attend the public workshop, you can register here.

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Tags: Bronchiectasis; NTM; Research FDA NTM Patient Voice Therapies
Categories: Research

Linhaliq/FDA Update

Posted on February 01, 2018   |   
Author: Gretchen   |   
2 Comments   |   
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Aradigm, the company that submitted Linhaliq to the FDA for approval, announced that they had received a complete response letter from the FDA stating that they would not approve the treatment at this time.

Over the last several months many of you have communicated with the FDA about the unmet need in the Bronchiectasis community. You told them your priorities, your needs and your frequent battles to keep exacerbations at bay.

While we are disappointed that important patient focused issues were not adequately addressed within the FDA’s response to Aradigm, we believe that your voices will make a difference in moving forward in the quest to identify and approve new treatments for bronchiectasis. We appreciate Aradigm’s commitment to addressing the needs of the bronchiectasis community and will continue to work with all stakeholders to improve the lives of people with bronchiectasis moving forward.

If you would like to read more about Aradigm’s announcement you can view the press release HERE.



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Tags: Bronchiectasis FDA Research Treatments
Categories: Research

The FDA NEEDS to Hear from You!!

Posted on January 23, 2018   |   
Author: Gretchen   |   
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The voice of the patient has a role in the drug development AND approval process. In fact, recent legislation mandates an increased emphasis on incorporating the patient perspective into the regulatory process.

Currently, there are no treatments that the FDA has approved specifically for bronchiectasis. On January 11th, 2018 the FDA convened a meeting of the Antimicrobial Drugs Advisory Committee to review the potential new treatment, Linhaliq, made by Aradigm, and make a recommendation to the FDA on whether or not to approve it for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with Pseudomonas aeruginosa lung infections. Linhaliq is an inhaled version of ciprofloxacin that has undergone several clinical trials to evaluate if it extends the time to the first exacerbation compared to a placebo treatment.

This was the second recent Advisory Committee meeting for a potential bronchiectasis therapy coming after a November meeting where the Committee reviewed and did not recommend another version of ciprofloxacin made by Bayer. The discussion and vote at the Linhaliq meeting were based on a specific and narrowly defined question about whether Aradigm had met the standards of safety and efficacy for the drug’s intended outcome, which was time to first exacerbation. Like the Bayer meeting, the committee voted that Aradigm had not met those standards, however the Advisory Committee only provides recommendations for the FDA to consider. The FDA then makes the final decision. However, an approval after a negative committee vote is very rare.

In this case, the process and the discussions that occurred at the meetings do not adequately reflect the needs, priorities and preferences of the patient community. We are asking you to take the time to read the below background information and use the bullet point template as a guide to share your perspective with the FDA as they enter this critical period of determining whether to approve the applications for inhaled ciprofloxacin.

What were the core issues at the Antimicrobial Advisory Committee Meeting?

  • The primary outcome that the FDA and the pharmaceutical companies used was time to first exacerbation which measured whether there was more time until the patient taking the treatment had an exacerbation as compared to those taking the placebo.
  • Time to first exacerbation is not felt to be the most appropriate outcome to use for the bronchiectasis population as it may not adequately reflect whether patients truly do better and feel better on the new treatment. The Advisory Committee even acknowledged this during their discussion.
  • The Committee, the FDA, the pharmaceutical companies, clinicians and patients have acknowledged that frequency of exacerbations is the better outcome measure.
  • The companies also collected data on whether the treatment lowered the frequency of exacerbations, however the Advisory Committee was not allowed to consider this data when deciding whether to recommend approval of the treatment because of the design of the trial and related regulatory review.

 

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Tags: Bronchiectasis Drugs Bronchiectasis Treatment FDA Linhaliq
Categories: Research

Is it possible that eating various foods can slow a lung function decline?

Posted on December 26, 2017   |   
Author: Gretchen   |   
3 Comments   |   
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Certain foods may slow declining lung function in smokers, nonsmokers, research suggests

NEWS WEEK (12/21, Matthews) reports that research suggests “certain foods may slow declining lung function both in smokers and nonsmokers.

The ATLANTA JOURNAL-CONSTITUTION (12/21, Parker) reports that investigators examined the diet and lung function of more than 650 adults in 2002, following up with the individuals 10 years later. The study participants completed a questionnaire, which assessed their eating habits, and they also underwent spirometry, a procedure that measures the capacity of lungs to take in oxygen.&

HEALTHY (12/21, Preidt) reports that investigators found that people who ate an average of more than two tomatoes or more than three portions of fresh fruit a day, especially apples, had a slower decline in lung function than those who ate less than one tomato or less than one portion of fruit a day. The link between diet and slower reductions in lung function was even more striking among former smokers, suggesting that nutrients in tomatoes and fresh fruit may help repair lung damage caused by smoking. The FINDINGS were published in the European Respiratory Journal.


 


 

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Tags: healthy eating lung function
Categories: Research

The FDA Wants to Hear From You

Posted on December 21, 2017   |   
Author: Gretchen   |   
2 Comments   |   
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The Food and Drug Administration (FDA) is responsible for deciding if new drugs and medical devices are safe and effective based on data typically produced by years of clinical trials. But, did you know that the FDA also considers information provided by patients when deciding whether to approve a new treatment or device?

Currently, there are no treatments that the FDA has approved specifically for bronchiectasis. On January 11th, 2018 the FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee to review the potential new treatment, Linhaliq, and make a recommendation to the FDA on whether or not to approve it for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections withPseudomonas aeruginosa. The new treatment is made by Aradigm. It is an inhaled version of ciprofloxacin that has undergone several clinical trials to evaluate if it extends the time to the first exacerbation compared to a placebo treatment. The potential to have new treatments indicated specifically for those with chronic lung infections with pseudomonas aeruginosa is particularly important for patients, because patients report a worse quality of life and have more hospital stays when pseudomonas aeruginosa is present.

Only you can truly help the Advisory Committee members who will review the new treatment understand what the unmet medical need is and what living with bronchiectasis is like. What type of impact do frequent lung infections and hospitalizations have on you? How are you currently managing your disease and what type of burden does that treatment place on you? How often do you end up on IV antibiotics every year?

These are just a few of the questions that you can address by participating in an open call for written comments leading up to the January 11th FDA hearing. During the meeting, the Advisory Committee is only able to set aside about an hour for public comments, which means not everyone at the meeting will have the opportunity to speak. Written comments are a great way to ensure that your voice can still be heard and your perspectives on life with bronchiectasis can be considered by the Advisory Committee members. At the end of the meeting, the Advisory Committee members vote on a series of questions that amount to a recommendation on whether the FDA should approve the new treatment. It is then up the FDA to make an official decision, but it is rare that they go against the recommendation of an Advisory Committee, making the opportunity to share your experiences with the disease even more important.

Ready to write a letter to the FDA? Here are a few tips to think about when writing.


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Tags: Bronchiectasis Drugs FDA Medical Devices
Categories: Research

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