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Warning Over Asthma Inhalers

Excessive use of reliever inhalers for asthma is linked to a significantly increased risk of dying from the disease, a new study revealed today.

Researchers found that over-use of short acting reliever drugs known as beta agonists is associated with a higher risk of death from asthma.

But regular use of inhaled steroids, known as longer acting preventer drugs, was linked with a decreased risk of asthma death.

They discovered that people prescribed more than one reliever inhaler a month cut their risk of death by 60% if they also regularly used a preventer inhaler.

The study was based on more than 96,000 patients in the UK diagnosed with asthma who were entered onto the General Practice Research Database between 1994 and 1998.

Of these, 43 had died from asthma, with 35 of the deaths in people aged 50 and above.

The research team from Connecticut, USA, calculated the relative risk of dying from asthma for people using the preventer and reliever drugs, taking into account factors such as the patients' age, sex, weight, smoking habits and frequency of GP visits.

They found that between seven and 12 prescriptions of reliever inhalers in the previous year increased the risk 16-fold and 13 or more prescriptions increased it by more than 50-fold.

The authors, writing in the journal Thorax today, state that asthma death is a rare outcome for which the rates have been declining.

But they say: "Despite the variety of respiratory medications available, inhaled steroids constituted the only class of respiratory drug in this study which was consistently related to a decreased risk of asthma death."

The British Thoracic Society said that reliever inhalers have their place in the management of asthma.

Dr John Harvey of the BTS said: "This research clearly demonstrates just how important it is for asthma patients to use both reliever and preventer medicines if they are prescribed by their GP.

"Both can have their place in managing mild and severe asthma correctly."

Preventer medication, which is usually in a brown, red or orange inhaler, helps to control swelling and inflammation in the airways for the long term.

Reliever inhalers, which are typically blue, are taken as required to relieve symptoms by relaxing muscles in narrowed airways.

The BTS said overwhelming research showed both forms of medication are safe and effective.

It is advising anyone concerned about using reliever inhalers to talk to their GP or asthma nurse.

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This 3M Smart Inhaler Tells You How To Use It

Manufacturing giant 3M is seeking to change the game when it comes to chronic obstructive pulmonary disease treatment.

Nancy Crotti

3M has announced a "smart inhaler" that not only connects wirelessly to a smartphone app but has a tiny screen that teaches patients how to use the device.

The 3M Intelligent Control inhaler is the latest entrant into a field that's become crowded with companies working to increase chronic obstructive pulmonary disease (COPD) patient compliance with treatment and decrease trips to the hospital. Research has shown that up to 70% of COPD patients use inhalers incorrectly.

3M has been working in inhalation development for 60 years. The company talked with healthcare providers and payers, all of whom said COPD patient compliance and adherence are bad.

3M incorporated electronics into the inhaler "to actually instruct the patient in real time how to use the device," said Steven Wick, technical director of 3M Drug Delivery Systems in St. Paul, MN. The device is designed to begin delivering the drug when the patient inhales and monitors drug delivery for deep, consistent lung penetration from dose to dose, Wick said.

The approximately 1-in.-by-1½-in. Screen will tell a patient if the inhaler is at the wrong angle, and will even count down the number of seconds the patient needs hold her breath after each inhale, Wick said. The inhaler will feed all of the information to the app, which will coach the patient on how to improve her technique. The app would also send patients reminders about taking their next dose.

The inhaler also has sufficient memory to know when a patient switches to a different medication, according to Wick. Pharmaceutical companies would not have to change their canister packaging, he added.

In a study of 26 adults aged 18 to 55, 95% used the inhaler properly with minimal instruction, Wick noted. Because many COPD patients are older, clinical trials will include them, he added.

The company expects to have documentation from Phase I and Phase II-A clinical studies by the end of this year, and for Phase III by mid-2017. If all goes well, 3M hopes to gain FDA approval in 2019.  Each pharmaceutical company that partners with 3M on using its drug in the device would need separate FDA approval as a drug-device combination, according to Wick.

Other companies, including Propeller Health in Madison, WI, have already won FDA approval for "connected" inhalers to help asthma and COPD patients with adherence. Propeller won its first FDA approval for asthma technology in 2012.  Most recently, the company obtained clearance for use of its technology with the GlaxoSmithKline Diskus dry powder inhaler and Boehringer Ingelheim's Respimat inhaler, marking the first time the system can be used to track daily medication use rather than only emergency-based medication use.

Propeller Health's technology can be used to drive adherence via messages on a user's smartphone in addition to email- and text-message-based reminders. The system is also compliant with the Qualcomm Life's 2net Hub.

3M's technology takes patient adherence one step further, according to Wick.

"We have been able to clinically demonstrate significantly better device competence versus a ["press and breathe"/standard inhaler] and Respimat device," Wick said in an email. "This improved device competence leads to significantly reduced variability in drug delivery--a two-fold reduction in variability versus a P&B device and a four-fold reduction in variability versus the Respimat device."  

Propeller CEO David Van Sickle did not immediately return a request for comment.

3M announced the smart inhaler at the Respiratory Drug Delivery conference in Scottsdale, AZ, this week, leading to lots of conversations with possible pharma partners.

"No one signed yet, but there's a lot of interest, a lot of excitement, so I expect we will start signing partners very soon," Wick said. "It can be customized to meet the pharmaceutical company's needs."

The device would be reusable for 12 months, one aspect that the company hopes will keep the overall cost down.

3M is focusing on COPD now, but may add inhalers for asthma patients down the road. 

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed and MPMN.

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Ava­lyn Rais­es $175M To Test In­haler Ver­sions Of IPF Med­i­cines In PhII Tri­als

Ava­lyn Phar­ma an­nounced Wednes­day that it closed a $175 mil­lion Se­ries C round, which it plans to put to­ward two Phase II stud­ies of in­haled ver­sions of id­io­path­ic pul­monary fi­bro­sis drugs.

Ava­lyn wants to test an in­haled ver­sion of pir­fenidone in a Phase IIb study. The pill is mar­ket­ed as Es­bri­et by Roche, though it lost patent ex­clu­siv­i­ty last year. Roche went to court in an at­tempt to keep gener­ics from en­ter­ing the mar­ket but did not suc­ceed, and in May of last year, San­doz launched a gener­ic ver­sion of the drug. Roche earned over $1 bil­lion from Es­bri­et in 2021, but sales have fall­en sub­stan­tial­ly from the new com­pe­ti­tion. In its sec­ond-quar­ter re­port in Ju­ly, Roche said Es­bri­et sales had fall­en 78% com­pared to last year.

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