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Linhaliq/FDA Update

Posted on February 01, 2018   |   
Author: Gretchen   |   
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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

Bronchiectasis and NTM 101 Town Hall Recording

Posted on December 28, 2017   |   
Author: Gretchen   |   
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Bronchiectasis and NTM 101 Town Hall Recording

We hope you were able to join us for our December 2017 Bronchiectasis and NTM 101: The Basics Town Hall Teleconference. We are pleased to offer you the full recording from this event below. The recording is free and can be accessed at any time.

During the 60-minute teleconference, expert speaker Dr. Kevin Winthrop offered an overview of bronchiectasis and NTM- what are these conditions and how do they relate to one another? What causes them? What are common symptoms of both conditions? He then discussed diagnosis and treatment in detail. There were two live question and answer sessions during the call comprising more than one-third of the hour.

More About Your Expert Speaker

Kevin Winthrop

Dr. Kevin Winthrop
Oregon Health & Science University, Portland, OR, USA

Kevin L. Winthrop is a Professor of Public Health and Associate Professor of Infectious Diseases and Ophthalmology at the School of Public Health and School of Medicine at Oregon Health & Science University (OHSU) in Portland, OR, USA.

Dr. Winthrop received his undergraduate degree in biology from Yale University, New Haven, CT, USA and his medical degree from OHSU. He completed his internal medicine residency training at Legacy Emanuel Hospital, Portland, OR. He completed an infectious disease epidemiology fellowship at the US Centers for Disease Control and Prevention (CDC). In 2003, Dr. Winthrop was conferred a masters in public health from the University of California, Berkley, CA, USA. In 2006, Dr. Winthrop returned to OHSU as Assistant Professor before progressing to his current appointment in 2012.

A former infectious disease epidemiologist in the Division of Tuberculosis Elimination at the CDC, Dr. Winthrop has co-authored more than 170 publications, many regarding the epidemiologic and clinical aspects of opportunistic infections associated with immune-mediated inflammatory diseases, particularly those related to biologic immunosuppressive therapies.

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Tags: Bronchiectasis Kevin Winthrop NTM Town Hall
Categories: Awareness

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

FDA Hearing: Ciprofloxacin Inhalation Powder

Posted on November 17, 2017   |   
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This blog post was written by Tracie Sullivan, Grassroots Manager, COPD Foundation.

My first week as a new staff member at COPD Foundation has been an exciting and busy one! Yesterday I had the pleasure of attending the Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee Meeting with six exuberant, welcoming, and passionate advocates. This committee hearing was discussing proposing a new drug application called ciprofloxacin inhalation powder, for reduction of exacerbations in non-cystic fibrosis bronchiectasis in adult patients with respiratory bacterial pathogens. The advisory panel is set up to make recommendations to the FDA about whether or not they should approve a drug. Committee members for this advisory council were made up of 16 individuals composed of doctors, medical professionals, higher education professors, clinical research, mathematical statisticians, consumer and patient representatives.

As the proceedings started, myself and my colleagues learned about the research behind ciprofloxacin inhalation powder, the results from the clinician trials, the biostatistics involved, and clinical safety. Once the afternoon session began, our advocates were able to stand in front of the committee members and share their stories with bronchiectasis. Our advocates included doctors, patients, and caregivers. Those who had been a part of the clinical trials and had seen significant improvements, and those who did not have the opportunity to be a part of the trial, and were looking for new medical treatment opportunities. These stories included the everyday challenges they face, the medical routes they must adhere to, the lifestyle changes they have had to make, and concerns about the lack of research and medical advancements. Each advocate discussed how this new and innovative drug could provide hope for individuals with bronchiectasis, how it could change their lives. How one less exacerbation could keep them out of the emergency room, could allow them to go to that family event they had missed years before, how their quality of life could be instrumentally improved.

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Tags: Advocacy Bayer Cipro FDA
Categories: Research Support

Foliage and the Respiratory Patient

Posted on October 31, 2017   |   
Author: Gretchen   |   
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This blog post was written by Katie Keating, RN, MS, patient advocate

Fun fall decorations, such as pumpkins, hay stacks and cornstalks are a great way to get in the autumn spirit. Who doesn't love stunning fall foliage? While most people enjoy the lingering warm weather, Indian summer and unseasonably warm temperatures can make allergy symptoms last longer.

Ragweed plants usually begin to pollenate in mid-August and may continue to be a problem until a hard freeze, depending on where you live. As ragweed season winds down in the North and Northeast, the leaves start to fall, ramping up mold production. When leaves just sit in your yard, moisture accumulates, accelerating mold growth. If you have mold allergies, these signs of the season can do a number on your health.

Mold spores that grow on dead leaves and release spores into the air are common allergens throughout the fall. Old spores may peak on dry, windy afternoons or on damp, rainy days in the early morning.

Mold is a non-scientific name for many types of fungi- unwanted patches of black, brown, blue, yellow, pink, green, smelly fuzzy growths. Molds, both indoors and outdoors require moisture.

A runny nose, itchy eyes and scratchy throat can arise as the days get shorter and the leaves begin to change.  Most commonly diagnosed mold related symptoms include: asthma, allergic rhinitis and nasal congestion, post nasal drip with sore throat, coughing and hoarseness.  Mold allergies can cause sleepless nights and daytime fatigue.

Allergies can have a huge impact on quality of life and it's completely unnecessary suffering. A few recommendations for avoiding allergens outside include the following:

 

  • Start taking allergy medications 1 to 2 weeks before ragweed season begins-but please, always check with your doctor before starting a new medication.
  • Camping and outdoor trips should not be scheduled during times of high pollen count, which is usually September to October for ragweed.

 

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Tags: bronch and NTM Fall tips Mold Respiratory
Categories: Awareness

Event Alert: Bronchiectasis and NTM Town Hall Teleconference

Posted on October 24, 2017   |   
Author: Gretchen   |   
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The COPD Foundation is excited to announce that we will be convening a 2-part town hall teleconference series about bronchiectasis and NTM. The first town hall teleconference is titled Bronchiectasis and NTM 101: The Basics and will be convened on Thursday, December 7, 2017 from 1:00pm to 2:00pm EST. This town hall teleconference will provide an opportunity for community members to learn the basics about bronchiectasis and NTM, as explained by expert speaker Dr. Kevin Winthrop of Oregon Health and Science University. The event will allow also for the opportunity for community members to ask Dr. Winthrop questions about bronchiectasis and/or NTM. Topics to be covered during this event are listed in the agenda below. We're looking forward to having you join us on our first-ever Bronchiectasis and NTM Town Hall Teleconference. Please REGISTER FOR THE EVENT HERE and mark your calendars accordingly!

Bronchiectasis and NTM 101: The Basics

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

1:05 – 1:20 pm An Overview of Bronchiectasis and NTM Kevin Winthrop, MD

- What are bronchiectasis and NTM? How do they relate?

- What causes these conditions?

- What are common symptoms of these conditions?

1:20-1:30 pm  Questions and Answers

1:30-1:45 pm  An Overview of Bronchiectasis and NTM cont’d – Kevin Winthrop, MD

- How are these conditions diagnosed?

- How are these conditions treated?

- What resources are available for patients?

1:45-1:55 pm  Questions and Answers

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

The second part of this town hall teleconference series will take a more in-depth dive into bronchiectasis and NTM and will be convened in early 2018. More details to come soon!


 

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Tags: Bronchiectasis Conference COPD Foundation
Categories: Research

Fire pits, Fireplaces and Chiminea-Tips for Respiratory Patients

Posted on October 17, 2017   |   
Author: Gretchen   |   
2 Comments   |   
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This blog post was written by Katie Keating, RN, MS, patient advocate

Firepits, Fireplaces and Chimineas-Tips for Respiratory Patients

Do you enjoy sitting around a crackling fireplace indoors or cozy firepit outdoors on a fall night? I have always loved doing so; it brings back fond childhood memories of toasting marshmallows or singing around the fire. Outdoor fires make you feel alive. The crackling sounds of indoor fireplaces, the hearth of a home are comforting, inviting.

I have been in denial about the possibility of fire smoke irritating my lungs or causing lung damage for years since I enjoyed using fireplaces and firepits so much. Over the past few years though, I have decided that it just is not worth taking a chance of injuring my lungs.  Hence, I no longer sit by a campfire, a firepit, chiminea or an indoor wood-burning fireplace. I value my health too much and will take any preventive measure to lessen the chance of aggravating the health of my lungs.

The best way to manage chronic lung disorders is to avoid the things that make them worse. It is so important to identify irritants that can trigger respiratory symptoms.

Burning wood releases pollutants into the air we breathe; wood smoke contains millions of tiny particles. Breathing in wood smoke can irritate sensitive airways, cause airway tightening, increase respiratory symptoms, increase hospital admissions, exacerbate COPD, and decrease your ability to breathe normally. Simply put, if you have a lung disease, breathing in wood smoke can make your disease worse and cause a flare-up.

Smoke isn’t the only health hazard you should avoid. Y The heat itself can be harmful. Inhaling air that is consistently at a higher temperature than the surrounding air can cause more damage to the lining of your lower respiratory tract than smoke inhalation. (1)

Environment Canada and Health Canada has identified many hazardous chemical substances in wood smoke, including: (2)

  • PM2.5 consists of a mixture of microscopic particles of varied size and composition and  has been declared a toxic substance under the Environmental Protection Act. These particles can be inhaled deep into the lungs, leading to serious respiratory problems, including mortality, especially among those with pre-existing cardiopulmonary illnesses.
  • Carbon monoxide (CO) can reduce the blood's ability to supply necessary oxygen to body's tissues, which can cause stress to the heart. When inhaled at higher levels, CO may cause fatigue, headaches, dizziness, nausea, confusion, and disorientation.
  • Oxides of Nitrogen (NOx) can lower the resistance to lung infections. In particular, nitrogen dioxide can cause shortness of breath and irritate the upper airways.
  • Hydrocarbons (HC) — can damage the lungs.

 

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Tags: Bronchiectasis Firepits NTM Respiratory
Categories: Awareness

The Bronchiectasis and NTM Information Line is now open!

Posted on September 25, 2017   |   
Author: Gretchen   |   
6 Comments   |   
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The COPD Foundation is happy to announce the release of the Bronchiectasis and NTM Information Line: 1-833-411-LUNG (5864). The Bronchiectasis and NTM Information Line is a toll-free number managed by the C.O.P.D. Information Line for peer-to-peer information and referrals on Bronchiectasis and NTM by patients and caregivers. Callers receive one-on-one support from an Associate that speaks English and Spanish.

All Information Line Associates are trained over a rigorous 80-hour process on customer service and call etiquette, service to sales, Health Insurance Portability and Accountability Act (HIPAA) compliance, patient resources, and the programs of the Bronchiectasis and NTM Initiative.

The Bronchiectasis and NTM Information Line is now available for patients, caregivers, and friends looking for more information. A live Associate can be reached Monday through Friday from 9:00am to 6:00pm ET.

 

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Tags: Bronchiectasis COPD Info Line NTM
Categories: Support

Why Weather can Worsen your Lung Condition

Posted on September 05, 2017   |   
Author: Gretchen   |   
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This blog post was written by Katie Keating, RN, MS, patient advocate

Weather can affect most of us in general, but understanding weather forecasts is especially important for people with respiratory disorders.  My objective is to discuss a few of the different terms often used during weather forecasts and to share experiences I have had in regard to the weather. I hope that this will help you to have a better understanding of their meaning and how they may impact you as a patient. I sometimes have days when I feel awful, not realizing that it is a temporary issue due to the weather. Please note that this is my experience, but this may not always be the case and you should always contact your doctor if you are unsure.

Dew point is the first temperature at which the moisture in the air begins or would begin to collect on surfaces. Humidity refers to the saturation of the water vapor or moisture and is expressed in percentages. 

A high relative humidity implies that the dew point is closer to the current air temperature. Relative humidity of 100% indicates the dew point is equal to the current temperature and that the air is maximally saturated with water.  High relative humidity is when air is holding as much water vapor as it can. For clouds to form, and rain to start, the air does have to reach 100% relative humidity. Typically, rain falls into air with less than saturated humidity. More moisture in the air results in less oxygen to breathe and some patients may experience bronchospasm. Bronchospasms are a spasm of bronchial smooth muscle producing narrowing of the bronchi.

The following link goes to a TEMPERATURE/DEW POINT/RELATIVE HUMIDITY CALCULATOR. Although this was designed to be used to preserve artifacts, it also provides an indication for possible humidity, mold growth, etc. Dew point is the better measurement of how humid the air feels.

Heat Index is a measure of how hot it really feels when relative humidity is factored in with the actual temperature. You can use this HEAT INDEX CALCULATOR of quantity expressing the discomfort felt as a result of the combined effects of the temperature and humidity of the air.

 

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Tags: bronch and NTM Quality of Life weather
Categories: Awareness

The Challenges of Summer for Respiratory Patients

Posted on July 14, 2017   |   
Author: Gretchen   |   
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This blog post was written by Katie Keating, RN, MS, patient advocate

Summer has finally arrived!!! It is a happy season for most people who enjoy spending more time outdoors. I loved summer to the nth degree when I was younger and before I experienced respiratory issues. Now, summers can be challenging for me for several reasons.

The warm temperatures are great as long as it is not too hot or humid. However, because high temps and high humidity can make respiratory patients feel exhausted quickly, I am now very cautious not to stay out too long on humid days because I know it will make me feel run down.  While every patient is different, historically, I have been ill with either MAC or another gram-negative infection every year in mid-August, over the past decade. My goal for this year is to prevent this reoccurrence.

Below are a few preventive measures that I am mindful of during the summer:

  • Pay attention to the weather channel to check when there are severe weather alerts for patients with respiratory issues.  Elevated ozone and particulate levels can greatly impact the way respiratory patients feel.It is wise to follow the recommendations made by your local weather channel to stay indoors during this time period. 
  • Stay hydrated with fluids. Water and non-carbonated beverages are the best choice. Caffeinated beverages may give a boost; however they can lead to dehydration. Avoid high sugar drinks since mycobacterium thrive in high sugar mediums. We also want to avoid the co-morbidity of type-2 diabetes.
  • Have an extra inhaler, nebulizer solution, and mucinex on hand in case you cannot get out to the drug store for a few days in the extreme heat.
  • Avoid hot tubs, as tempting as they may be, since mycobacterium can dwell in hot tubs and easily become airborne.

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Tags: bronch and NTM preparations Summer Tips
Categories: Quality of Life

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