NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

The Air Next Spirometer was granted 510k approval for in-home use by the NuvoAir clinical team and its clinical trials partners.

January 25th, 2024 – Boston, MA: NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir to scale and expand clinical operations to ensure no patient with heart or lung conditions is left behind.

510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary. For patients with conditions like COPD, Asthma, or ALS, using this easy-to-use device at home means they don’t have to wait for an in-person appointment or plan the logistics for travel.

“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” says Eric Harker, MD MPH MBA, and Chief Medical Officer at NuvoAir. “Spirometry has traditionally been underutilized as a diagnostic and monitoring tool because of the logistical challenges of getting complex patients to a clinic with regularity. In-home spirometry empowers our practice to provide continuous care to our patients in the home with real-time, high-quality, and actionable clinical data.”

By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe. “Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” says Furat Shawki, General Manager of Clinical Trials at NuvoAir. “With in-home approval of ATS 2019-compliant spirometry, we can look forward to scaling our services with our partners across the healthcare ecosystem, including healthcare providers and clinical trials, so we can deliver the cardiopulmonary care that people desperately deserve to the places that need it most.”... NuvoAir Medical's Press Release - 

Synairgen : Positive Phase II asthma clinical trial data

April 19, 2012 - Synairgen plc (LSE: SNG), announces positive data from its Phase II clinical trial. This pioneering trial investigated the potential for SNG001 (inhaled interferon beta) to protect asthmatics from respiratory virus infections (principally the common cold) that can spread to the lung, which are a major cause of worsening asthma symptoms. It is estimated that viral infection is associated with up to eight out of ten asthma-related emergency department visits.

There are 5.4 million asthmatics in the UK (Asthma UK) and 25.7 million in the USA (Centers for Disease Control and Prevention).

The study investigated SNG001 in a population of 134 adult asthma patients, representing 'mild-moderate' through to 'severe' asthmatics, who caught a cold. Patients with 'difficult to treat' asthma, being approximately half of the patients in the trial, benefitted significantly from SNG001 treatment. This category of patient is estimated to represent between 10% and 20% of all adult asthma sufferers... [PDF] Synairgen's Press Release -

PhRMA : More Than 70 Medicines in Development for Asthma

March 5, 2012 — America’s biopharmaceutical research companies are developing 74 medicines to treat or prevent asthma, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration.

“Asthma is a lifelong disease that can limit a person’s quality of life and even lead to death, if not treated properly,” said PhRMA President and CEO John J. Castellani. “The good news is that potential treatments highlighted in this report offer asthma sufferers new hope of living a healthier, more productive lives.”

Asthma is a narrowing of the airways to the lungs caused by inflammation in the air passages, resulting from both genetic and environmental influences. Today, more than 24 million American adults and children suffer from asthma, with the prevalence increasing 12 percent in the last decade, according to the Centers for Disease Control and Prevention. Each day, 40,000 Americans miss school or work due to asthma, costing the U.S. economy an estimated $56 billion each year in direct and indirect costs... PhRMA's Press Release -

GSK: Professor Rob Horne discusses the MyAsthma programme

Nycomed and Orion : to collaborate on Easyhaler® for asthma and COPD

4 August 2011 - Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) announced that it has entered into a collaboration agreement with Nycomed for the co-marketing of Easyhaler® combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialise Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD (chronic obstructive pulmonary disease). Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler® research programme in progress to develop a fluticasone-salmeterol formulation. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas® (roflumilast), Alvesco® (ciclesonide) for asthma, and Omnaris® for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion's strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area - in which both companies present their own product brands under the Easyhaler umbrella brand - covers the major European countries including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, U.K. and Eastern Europe where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement... Orion's Press Release - Nycomed's Press Release -

Revalesio : research on the anti-inflammatory effects of RNS60 in Asthma

March 16, 2011 – Revalesio Corporation announced that research related to the use of RNS60, its novel anti-inflammatory, will be featured in two poster presentations at the Annual Meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco on March 18-22.
AAAAI is the largest professional organization in the United States devoted to the specialty of allergy and immunology. It has nearly 6,500 members in the United States, Canada and 60 other countries.
Revalesio will present findings that demonstrate the novel anti-inflammatory activity of charge-stabilized nanostructures both in a preclinical model of allergic asthma and in cell culture experiments. These data suggest that Revalesio’s novel therapeutic RNS60 provides an opportunity for the development of a new generation of low-risk therapeutics for inflammatory pulmonary diseases.

In the preclinical model of asthma, RNS60 showed significant efficacy in the reduction of key inflammatory cytokines, including interleukin-6, interleukin-4, tumor necrosis factor-α (TNF-α), eotaxin and other cytokines known to be drivers of asthma. In addition to reducing inflammatory cytokines, RNS60 improved respiratory parameters compared to treatment with the inhaled corticosteroid budesonide... Revalesio's Press Release -

Ligand Acquired Milestone and Royalty Interest in AstraZeneca IL-9 Program for Asthma

May 21, 2010 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has purchased from the Genaera Liquidating Trust certain intellectual property and interests in future milestones and royalties for MEDI-528, an IL-9 antibody program under development by AstraZeneca's subsidiary, MedImmune. MEDI-528 is currently in a 320-patient Phase II study for moderate-to-severe asthma.


Ligand paid $2.75 million to the Genaera Liquidating Trust in connection with the purchase. This opportunity arose from initial diligence and work conducted by Biotechnology Value Fund, L.P. (BVF). As part of this transaction and a result of BVF's contributions, Ligand entered into a separate agreement with BVF and certain of its affiliates, whereby BVF and Ligand will share the purchase price and any proceeds from the deal equally. Accordingly, BVF has paid Ligand $1.375 million... Ligand Pharmaceuticals' Press Release -

FDA Approves Merck's DULERA® Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older

June 24, 2010 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The approval of DULERA is based, in part, on Phase III studies that evaluated the safety and efficacy of DULERA in patients 12 years of age and older with persistent asthma.

"Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,”... Merck's Press Release -

Palatin Technologies : Positive Preclinical Data with PL-3994 for Asthma Indications

June 21, 2010 – Palatin Technologies, Inc. (NYSE Amex: PTN) announced results of preclinical studies in respiratory tissue with PL-3994. In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

PL-3994 is a proprietary peptide mimetic that binds and activates natriuretic peptide receptor A, a guanylate cyclase. Naturally occurring natriuretic peptides have been evaluated for bronchodilator activity in previous clinical studies with asthmatics. Despite positive outcomes, no commercial products have been developed in part, Palatin believes, because of the very short half-life of those molecules. In earlier Phase 1 clinical studies conducted by Palatin, PL-3994 has been shown to have a significantly longer half-life than endogenous natriuretic peptides, with biological effects attributable to relaxation of smooth muscle seen for up to eight hours following single administrations in man... Palatin Technologies' Press Release -

Sandoz : acquisition of Oriel Therapeutics, strengthening potential for global leadership in respiratory

June 3, 2010– Sandoz announced that it has completed its acquisition of Oriel Therapeutics, a privately held US pharmaceuticals company, for an undisclosed sum.

• Closure gives Sandoz rights to several promising development projects, as well as to novel FreePath™ drug delivery system and Solis™ multi-dose dry powder inhaler
• Regulatory approvals, if achieved, would broaden access to affordable, high-quality respiratory medicines and reinforce Sandoz’s position as a leader in differentiated generics...

[...]

...Oriel focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). Regulatory approvals of these medicines, if achieved, would enable Sandoz to increase access to affordable, high-quality therapeutic alternatives for these increasingly prevalent diseases... Sandoz's Press Release -

Verona Pharma : AGM Statement

3 June 2010 -...“In the twelve months since the last AGM Verona Pharma has seen significant progress in its drug development programmes.
“Highlights

• Successfully completed Phase I/IIa clinical trial of RPL554 and licensing discussions are progressing.
• Conducting further studies for RPL554 to add value to the licensing package and strategically prepare the drug for further clinical trials.
• VRP700 - regulatory documents have been finalised and awaiting submission to the appropriate regulatory and ethical authorities.
• NAIPs – continuing to evaluate novel compounds from collaborative partners, to determine clinical potential as anti-inflammatory drug candidates.
• Maintaining low burn rate, currently with approx. £3m in cash.

“Since successfully completing its Phase I/IIa clinical proof of concept trial of RPL554, leading to the issue of the quality assured report by the Centre for Human Drug Research ("CHDR"), discussions with potential licensing partners have been progressing. While discussions continue, we are adding value to the RPL554 licensing package by conducting further studies. Treatments for asthma and COPD are commonly delivered using a dry powder inhaler and we have conducted experimental studies to confirm that RPL554 can be administered in this form. In addition we are carrying out further clinical studies on the safety of RPL554 at higher doses, the duration of action with respect to bronchodilation, and the extent of its anti-inflammatory action. These additional studies are expected to increase the Company’s Intellectual Property package concerning RPL554; in turn strengthening our position during licensing discussions and increasing RPL554’s value... [PDF] Verona Pharma's Press Release -

Centocor Ortho Biotech Acquires RespiVert Strengthens Pulmonary Focus

June 1, 2010 - Acquisition Bolsters Pulmonary Portfolio and Capabilities, Accessing Promising Pipeline of First-in-Class Compounds and Renowned Team of Respiratory Scientists – Centocor Ortho Biotech Inc. announced that it has acquired RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases. The company’s lead compounds, RV-568 and RV-1088, narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities, are progressing into clinical development as potential first-in-class treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).


The clinical development of RV-568 and RV-1088 will be led by RespiVert in collaboration with scientists at Centocor Research and Development, Inc. The company is not disclosing financial terms... Centocor Ortho Biotech [JNJ] -

Funxional Therapeutics : ...10 million Euros... to fund the initial Phase II clinical studies of FX125L in inflammation

26 May 2010 - Funxional Therapeutics Ltd (Funxional Therapeutics) announced the completion of a Series B financing round in which it raised a total of EUR 10 million (US$ 12.5 million). Ventech participated as a new investor in this round, together with existing investors Index Ventures and Novo A/S.
The capital raised enables Funxional Therapeutics to further progress the development of novel anti-inflammatory therapies that belong to a new class referred to as Broad Spectrum Chemokine Inhibitors (BSCIs). The Company’s lead drug candidate, FX125L, an orally available small molecule, is ready for Phase II studies in different inflammatory conditions. The preclinical development of back-up compounds to FX125L will also be advanced in parallel...

[...]

...About BSCIs
BSCIs are a new class of anti-inflammatory compounds with an entirely novel mechanism of action that involves the selective interaction with a well-characterised receptor (which is distinct from the chemokine receptor) and results in a potent inhibition of inflammatory cell migration. The compounds are anticipated to have broad applications in major inflammatory diseases such as asthma / COPD, RA, psoriasis and IBD... [PDF] Funxional Therapeutics' Press Release -

Cytokinetics : Non-Clinical Data from Its Smooth Muscle Contractility Program at the American Thoracic Society’s 2010 International Conference

May 18, 2010 - Inhibitors of Smooth Muscle Myosin May Offer a Novel Therapeutic Approach to the Treatment of Chronic Obstructive Pulmonary Disease and Asthma - Cytokinetics, Incorporated (Nasdaq: CYTK) announced that a poster summarizing non-clinical data regarding its smooth muscle contractility program was presented at the American Thoracic Society’s 2010 International Conference which was held May 14-19, 2010 at the Ernest N. Morial Convention Center in New Orleans, LA... Cytokinetics' Press Release -

NexBio : Clinical Trial of DAS181 (Fludase®*) in Asthmatics Initiated at the National Institutes of Health

May, 3, 2010 – NexBio, Inc. announced the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.
DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma... [PDF] NexBio's Press Release -

Graceway Pharmaceuticals : Maxair Autohaler Remains Available Through December 31, 2013

04/19/2010 - Graceway Pharmaceuticals, LLC announced that the Food and Drug Administration (“FDA”) published a long-awaited Final Rule regarding the continued availability of Maxair Autohaler (pirbuterol acetate inhalation aerosol) and other pressurized metered-dose inhalers containing chlorofluorocarbons (CFCs). Under the rule, Maxair Autohaler will remain available for physicians and patients through December 31, 2013.

In support of its decision, FDA noted that it received a large number of comments from physicians and patients addressing the public health benefits of pirbuterol – the active ingredient in Maxair Autohaler. FDA likewise observed that the need for patient education was an important factor in extending the effective date of the rule, and the Agency committed to actively monitor the patient transition to CFC-free alternatives... Graceway Pharmaceuticals' Press Release -

Phadia : point of care in vitro specific IgE allergy test into the physician’s office with final FDA clearance of the ImmunoCAP Rapid System

January 25, 2010 – Phadia, the world leader in allergy blood testing diagnostics, today announced that the United States Food and Drug Administration (FDA) has cleared the ImmunoCAP® Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office.
This clearance now allows Phadia to begin marketing the ImmunoCAP Rapid System to physicians throughout the United States having laboratories that meet CLIA standards for Moderately Complex testing. The test requires a simple capillary blood draw and test results are available to the physician in 20 minutes.

Up to 90% of all paediatric asthma patients have allergies and up to 60% of adult asthma patients have allergies that trigger their asthma attacks. Reducing exposure to these allergens is a key recommendation of the NIH-funded National Asthma Education and Prevention Program and is an important step in the effective management of allergic asthma... Phadia's Press Release -

Clinical Data : Results of Phase I Studies of Stedivaze™ Demonstrating Safety and Tolerability in Patients with Asthma and COPD

March 30, 2010 - Enrollment continues in Phase III ASPECT trial of Stedivaze – Clinical Data, Inc. (NASDAQ: CLDA), announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
“The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations,”... [PDF] Clinical Data's Press Release -

Vectura to receive $9.5m payment and up to $25m loan facility

18 March 2010: Vectura Group plc (LSE: VEC), the specialty pharmaceutical company, announces that it has agreed with Sandoz AG to take full control of the US development and commercialisation of VR315, its combination product for asthma/COPD. Good progress continues to be made with the development of VR315. In Europe, there is no change to the agreement signed in April 2006, and Sandoz will continue to be fully responsible for the development, manufacture and commercialisation of the product.


Under the revised agreement, Vectura regains full rights and responsibilities for the development and commercialisation of VR315 in the US and is released from its profit share obligations. The reacquisition of full control of this important product in the US is part of Vectura’s strategy to become a cash-generative specialty pharmaceutical company, and VR315 will form the cornerstone of Vectura’s nascent US operations... Vectura's Press Release -

Oxagen : Completion of Recruitment in Phase IIb Dose Range-Finding Clinical Trial in New Oral Treatment for Asthma

9th December 2009 – Oxagen Limited, a drug discovery and development company specializing in inflammation, announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

The study, which was initiated in mid May 2009, is expected to complete by the end of Q2 2010. It involves 440 asthmatic patients with moderate persistent asthma who will be randomised to one of three possible dose levels of OC000459 or placebo by oral tablet for a 12 week dosing period, with lung function (improvement in clinic FEV1) being the primary end point.

The purpose of the study is to determine the magnitude of further improvement in lung function and asthma symptoms on longer term therapy and to define the optimal once daily oral dose of OC000459... Oxagen's Press Release -