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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.

Their voices, along with the dozens of patients who submitted written comments prior to the meeting, were heard loud and clear and we want to say THANK YOU!

The Advisory Committee was asked to vote on three questions including whether the primary outcome of culture conversion was clinically meaningful, whether the data showed that Arikayce was safe and effective for all NTM lung disease caused by MAC, and whether Arikayce was safe and effective for NTM lung disease cause by MAC in those who have not achieved culture conversion on standard antibiotic regimens. There was a great deal of discussion about what it meant to a patient to have a negative culture and how that translates to feeling better and doing better. In the end, the Committee voted 8 to 6 in support of culture conversion being a meaningful benefit.

Most importantly, the Committee voted 12 to 2 that Insmed had shown that Arikayce was a safe and effective treatment for those who have limited or no other treatment options. Since all of the patients who participated in the trials had already been on standard therapy, the Committee did not vote favorably that it was safe and effective for all patients but further studies that include newly diagnosed or untreated patients could change this in the future.

We are very pleased with the positive outcome that reflects the strong data that Insmed presented for those patients with nowhere else to turn. While this is not the final say in the approval of the therapy, the final decision will be made by the FDA’s Division of Anti-Infective Products, the COPD Foundation is optimistic that they will follow suit after reviewing the data, results, and comments by the research and the patient community.

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

Lend Your Voice to Raising Supplemental Oxygen Awareness

Posted on August 02, 2018   |   
Author: Gretchen   |   
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Mary Kitlowski, a member of BronchandNTM360social and COPD360social is in search of individuals who use supplemental oxygen (or a friend or family member who does) to share their stories. In childhood Mary was diagnosed with a rare genetic disorder called Primary Ciliary Dyskinesia (PCD) and later Bronchiectasis. She’s always had a passion for running and created an organization called Running on Air http://www.runningonair.net/virtual-racesthat seeks to advance awareness of lung diseases and other rare illnesses, to raise funds for organizations that seek to raise the same awareness and to inspire anyone who suffers with a disability to continue to exercise and live a healthy existence no matter the condition.

For much of the month of August, Mary hopes to share a story a day about individuals who use supplemental oxygen. She also plans to create a supplemental oxygen fact sheet. If you or someone you know would like to share your story and lend your voice to raising awareness on supplemental oxygen, please send your story and photo(s) to: Mary.RunningOnAir@verizon.net by August 10, 2018.The stories and photos will be highlighted on Running on Air’s Facebook page.

The story should include:

  • 1-3 paragraphs
  • Why is the individual on oxygen?
  • What has changed due to the supplemental oxygen?
  • Have any obstacles been overcome due to the oxygen therapy?
  • Since beginning supplemental oxygen, what can the individual no longer do?
  • Anything else that may be relevant to the story
  • A photo with the supplemental oxygen, if possible

Thank you for considering a contribution to this important endeavor. An unknown author said, “One voice can make a difference. A million can change the world.” We have to begin somewhere.

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Tags: Awareness Bronchiectasis Running on Air
Categories: Awareness

Upcoming FDA Advisory Committee Meeting for ALIS

Posted on July 12, 2018   |   
Author: Gretchen   |   
1 Comments   |   
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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

COPD, Bronchiectasis and NTM Webinar Recording

Posted on July 09, 2018   |   
Author: Gretchen   |   
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We hope you were able to join us for our June 2018 webinar with expert speaker Dr. Charles (Chuck) Daley. We are pleased to offer you the FULL RECORDING of this event. This recording is free and can be accessed at any time.

During the 60-minute webinar, Dr. Daley offered an overview of COPD, bronchiectasis and NTM, including how these conditions relate to one another as well as treatments for each condition. There were two live question and answer sessions during which members of the audience were given the opportunity to ask questions of the expert speaker.

Dr. Charles (Chuck) Daley

National Jewish Health, Denver, CO, USA

 

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Tags: Awareness Bronchiectasis Treatment Bronchiectasis; NTM; Research COPD NTM Treatment
Categories: Awareness

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

Event Alert: An Introduction to Bronchiectasis & NTM Webinar

Posted on June 01, 2018   |   
Author: Gretchen   |   
1 Comments   |   
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The COPD Foundation is convening a webinar to educate the COPD community on bronchiectasis and NTM lung disease. Join us for An Introduction to Bronchiectasis and NTM on Wednesday, June 20th from 1:00-2:00pm ET. Expert speaker, Dr. Charles Daley from National Jewish Health will provide an overview, covering the agenda items listed below, and answer questions that community members may have. This event is free, at no cost to the participants, but registration is required. Please click here to register for the event and mark your calendars! You will receive an email with connection instructions upon registering.

An Introduction to Bronchiectasis and NTM

1:00 – 1:05 pm Welcome and Introduction – COPD Foundation

1:05 – 1:20 pm Overview of COPD, Bronchiectasis and NTM – Chuck Daley, MD

· What are COPD and bronchiectasis? 

o How do they relate?

o How do they differ?

· What causes these conditions?

· What are common symptoms of these conditions?

· How are they diagnosed?

1:20 – 1:30 pm Questions and Answers

1:30 – 1:45 pm Overview of COPD, Bronchiectasis and NTM – Chuck Daley, MD

· What are NTM?

· How do they relate to COPD and bronchiectasis?

· How are NTM treated in these conditions?

o How is treatment similar?

o How is treatment different?

· What resources are available for patients?

BRONCHIECTASIS AND NTM INITIATIVE WEBSITE/COMMUNITY

BRONCHIECTASIS AND NTM INFORMATION LINE: 1-833-411-LUNG (5864)

NTM INFO & RESEARCH WEBSITE

1:45 – 1:55 pm Questions and Answers

1:55 – 2:00 pm Closing Remarks COPD Foundation

 

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Tags: Bronchiectasis COPD Education Dr. Charles Daley NTM
Categories: Awareness

How Caregivers Can Practice Self-Care

Posted on April 24, 2018   |   
Author: Gretchen   |   
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This blog post was written by guest writer, Harry Cline, author and caregiver

 

For many caregivers, finding the best ways to ensure their loved one is well taken care of while also taking care of their own needs can be overwhelming. This is especially true for those who are charged with caring for an elderly family member. Balancing self-care with the correct amount of attention to their patient’s needs isn’t always easy and can lead to guilt or other negative emotions. It’s important to remember that, as a caregiver, it will be impossible for you to properly tend to your patient if you yourself aren’t happy and healthy. There are more tips and resources at the Caregiver Action Network.

Self-care involves a number of aspects, from ensuring that you get enough rest, to figuring out a daily exercise routine that will help you stay strong. Caregiving can take a physical toll, so finding a good way to keep yourself fit and in shape will help prevent injuries. 

Get in a workout

Taking care of your body is an essential part of being a caregiver and it can help you stay healthy while giving you an outlet for any frustrations or negative feelings you may have. Create a daily workout routine that incorporates all the things you need to feel good. One great exercise is yoga because it keeps you physically fit while allowing you to meditate and focus on the present moment, which will lower your anxiety. Also, consider learning more about stretching, which is wonderful for relieving stress. There are several stretchesthat can be done anywhere, and quickly, which makes it easy to fit stretching into your daily routine.

Surround yourself with support

Caregiving can be a very demanding job in a lot of ways, so it’s important to surround yourself with people who support youand will help out when you’re feeling overwhelmed. It’s also a good idea to maintain a healthy social life since being a caregiver will often require that you to be present for your loved one for many hours of the day. Maintaining friendships and other relationships will help your mental health even when the work becomes difficult. 

Eat well

Because caregiving can be such a difficult job, it’s essential to keep your strength up. Eating well-balanced mealswill help give you the strength—physically and mentally―to carry out even the most demanding tasks during the job. Pay attention to your body and its needs, particularly when it comes to the times between meals. If you work long hours, pack healthy, protein-rich snacks that you can grab quickly. 

Find a hobby

Having a hobby that you enjoy doing is a great way to relieve stress at the end of a long day, and it can help act as a sort of therapy when you’re feeling down. Whether it’s something creative, such as painting or writing, or social, such as playing basketball with a group of friends, having something to look forward to will let you release energy and make you feel healthier.



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Tags: Caregivers Exercise support
Categories: Quality of Life

Applying for Disability Benefits

Posted on April 02, 2018   |   
Author: Gretchen   |   
13 Comments   |   
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This blog post was written by Cynthia Flora, patient advocate and head of NTM Support Group

Applying for disability with the Social Security Administration (SSA) can be a daunting task, but also is working with chronic lung conditions. My best piece of advice is EDUCATE YOURSELF AND PUSH FORWARD. If your symptoms and/or side effects from medications are making it difficult to work, think about getting more information and possibly applying. Typically, this process gets more difficult each year as the agencies have less money and our population ages. The level of difficulty will depend in part upon your local office.

I was lucky enough to find knowledgeable, kind employees that I could sit down with and actually helped talk me through the process. Go in armed with a clear one-page synopsis of dates, diagnoses, symptoms, and ways your condition affects your work, etc. You can always expand from there. If you cannot go in person and have to do it via phone, I would not recommend spending much time with a worker who is not being helpful, even though you may have to wait for another phone rep. Keep in mind that a bit of kindness and gratitude on the phone often goes a long way when you are asking someone to help.

Everyone is on his or her own journey. As for me, not long after I began a three year stint on the "big three antibiotics", it was obvious to me that my new job should be staying well. Exhaustion and the fear of getting the flu or an upper respiratory infection every time I used a phone, computer, or fax machine that a sick co-worker had just touched made work a huge impediment.

In general, the older you are, the sicker you may be, and the more difficulties you face doing your current job are key factors. You do NOT want to put a brave face on your condition. You want them to understand how difficult your worst days can be. If awarded disability your monthly payment will be the amount you would receive had you remained working and applied for Social Security at your full retirement age. This varies with age due to the government chipping away at benefits. You can look it up on your individual SSA account or call the SSA if you can't figure it out.

HTTPS://WWW.SSA.GOV/DISABILITY/

HTTPS://WWW.DISABILITYBENEFITSCENTER.ORG/SOCIAL-SECURITY-DISABLING-CONDITIONS


 

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Tags: Applying for social security bronch and NTM disability respiratory issues
Categories: Awareness

A Dive Into Bronchiectasis and NTM Town Hall Teleconference Recording

Posted on March 26, 2018   |   
Author: Gretchen   |   
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A Dive into Bronchiectasis and NTM Town Hall Teleconference Recording

We hope you were able to join us for our March 2018 A Dive into Bronchiectasis and NTM Town Hall Teleconference. We are pleased to offer you the full recording from this event. The recording is free and can be accessed at any time.

During the 60-minute teleconference, expert speaker Dr. Tim Aksamit offered an overview of bronchiectasis exacerbations, including the treatment and prevention of exacerbations. He also covered environmental factors associated with NTM and the treatment of NTM lung infections, along with other comorbidities of bronchiectasis. There were two live question and answer sessions during the call comprising more than one-third of the hour.

Tim Aksamit, MD

Mayo Clinic, Rochester, MN, USA

Tim Aksamit is a consultant and associate professor in the pulmonary disease and critical care medicine division of Mayo Clinic, Rochester, MN, USA. 

Dr. Aksamit received his undergraduate degree in chemistry from the University of Illinois in Urbana, IL; medical degree from Northwestern University in Chicago, IL, and medical training in internal medicine as well as pulmonary and critical care medicine at the University of Iowa in Iowa City where he also was a chief resident. Additional research was completed at Hammersmith Hospital in London, U.K. Prior to joining the staff at Mayo Clinic in 1998 he was in private practice in Madison, WI. He has also previously served as the director of the medical intensive care unit at St. Mary’s Hospital Mayo Clinic, Rochester, Minnesota.


 


 

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Tags: Aksamit Bronchiectasis; NTM; Research Research Town Hall
Categories: Awareness

To Be or Not To Be Compliant-That is the Question

Posted on February 16, 2018   |   
Author: Gretchen   |   
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This blog post was written by Katie Keating, RN, MS, patient advocate

Are you compliant with your everyday NTM/bronchiectasis routine?

As we are still early into 2018, I read that only 8% follow through with their New Year’s resolutions. Was one of your New Years’ resolutions to work towards being as healthy as possible under the present circumstances?

Most people (not including NTM/bronchiectasis patients) get up, maybe have their coffee, take a shower and get ready to use their “taken for granted” energy to get going and have a very productive day. NTM /bronchiectasis patients start their day off more slowly, often after less than a superb night’s sleep. Most choose not to take a quick shower but a slow bath in attempt to avoid meeting mycobacterium from their showerhead. Many avoid coffee due to acid reflux issues. 

Some patients are affected by daily variables in the weather. Many wait and see how they will feel on any given day before they approach their tasks of the day. Many patients do not get up and go to work (or to an activity that they truly enjoy) on a daily basis due to not feeling up to par. Staying home can get very old very quickly regardless of where you live, the home you reside in, especially if you are a social person.

The daily tasks of an NTM/Bronchiectasis patient may include the following: 

· Airway clearance either with a vest, accopella, flute, aerobica 

· Pulmonary rehabilitation

· Daily nasal washes

· Medications

· Labs


 

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Tags: Bronchiectasis compliancy daily routine nasal wash NTM
Categories: Awareness

Event Alert: Second Town Hall Teleconference: A Dive into Bronchiectasis and NTM

Posted on February 06, 2018   |   
Author: Gretchen   |   
12 Comments   |   
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We are excited to announce the second part of our two-part town hall teleconference series: A Dive into Bronchiectasis and NTM. This town hall event will take place via teleconference (no visual portion) on Monday, March 5thfrom 2pm to 3pm EST. Expert speaker, Dr. Tim Aksamit of the Mayo Clinic will take a dive into bronchiectasis and NTM by covering the topics listed in the agenda below. This event is free, but registration is required to participate. Please CLICK HERE to register for the event and mark your calendars accordingly! You will receive the dial-in details upon submission of the registration form.

A Dive into Bronchiectasis and NTM

2:00 – 2:05 pm    Welcome and Introduction – COPD Foundation

2:05 – 2:20 pm    Exacerbations – Tim Aksamit, MD

 

· The vicious cycle of bronchiectasis

o Heterogeneous causes, chronic disease

· What is an exacerbation?

· Treatment of acute exacerbations of bronchiectasis

· Preventing exacerbations

o Pulmonary hygiene/airway clearance/exercise

o Pulmonary rehabilitation

o Vaccines

2:20 – 2:30 pm Questions and Answers

2:30 – 2:45 pm NTM and Comorbidities – Tim Aksamit, MD

· Environmental reservoirs of NTM: soil and water

· Treatment of NTM lung infections- overview

o Mycobacterium Avium Complex (MAC)

o Mycobacterium Abscessus

o Mixed NTM infection

o Other NTM

· Comorbid issues: Gastroesophageal Reflux Disease (GERD), sinus disease, other

· Research and involvement

2:45 – 2:55 pm Questions and Answers

2:55 – 3:00 pm Closing Remarks – COPD Foundation

 

 

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Tags: Aksamit Bronchiectasis Research
Categories: Awareness

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

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