New nebulized combo therapy rapidly boosts lung function in COPD
AERO-007 has potential to fill significant gap in care, developer says
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AERO-007 — a combination of two classes of bronchodilators delivered via a standard jet nebulizer — led to rapid and clinically meaningful improvements in lung function among adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
That’s according to data from the Phase 2a portion of a Phase 1/2a clinical trial (NCT06841640) that tested AeroRx Therapeutics‘ nebulized combination therapy against a placebo in adults with moderate-to-severe COPD. The results were presented at the 2026 American Thoracic Society (ATS) International Conference, held in Florida last month.
AeroRx believes the findings support continued development of AERO-007 as a potential once-daily, first-line maintenance therapy for COPD patients who prefer or require nebulized versus handheld inhaled treatment. Nebulizers use a machine to convert liquid medication into a fine mist that can be breathed in.
“Patients in this segment have not had access to guideline-preferred [LABA plus LAMA] combination therapy in a fixed-dose nebulized formulation,” Ahmet Tutuncu, MD, PhD, co-founder and CEO of AeroRx, said in a company press release. “By combining two clinically validated bronchodilators in a proprietary formulation delivered through a standard jet nebulizer, we believe AERO-007 has the potential to address this significant gap in COPD care.”
Guidelines strongly recommend combining LABA and LAMA therapy
COPD treatment usually involves bronchodilators, medications that open and relax the airways. This includes long-acting beta-two agonists (LABAs) and long-acting muscarinic antagonists (LAMAs).
LABA medications include formoterol (sold as Perforomist, among others, with generics available) and Serevent (salmeterol), while LAMA medications include tiotropium (sold as Spiriva Respimat and Spiriva) and Tudorza Pressair (aclidinium).
The ATS’ 2020 guidelines strongly recommend combining LABA and LAMA therapy over either treatment alone for COPD patients experiencing shortness of breath or limited exercise tolerance.
While several LABA/LAMA combinations are currently available as handheld inhalers, a significant number of COPD patients, particularly older and higher-risk individuals, don’t receive optimal benefit from these devices.
“Dual bronchodilation is a central part of COPD maintenance therapy, but delivery remains an important barrier for many patients,” said Dave Singh, MD, professor of respiratory medicine and clinical pharmacology at the University of Manchester in the U.K and principal investigator of the Phase 2a study.
Phase 1 determined optimal fixed dose of both bronchodilators
Nebulized delivery using a device that converts liquid medication into a fine mist offers a passive-breathing alternative for these patients. Yet, nonebulized LABA/LAMA fixed-dose combination has been approved for COPD to date.
Developed via a partnership between AeroRx and HCmed, AERO-007 combines a fixed dose of indacaterol (a LABA) and glycopyrrolate (a LAMA), both of which are approved in the U.S. as part of combination treatments. It’s delivered using a standard jet nebulizer, which is also approved by the U.S. Food and Drug Administration.
The Phase 1 portion of the trial determined the optimal fixed dose of both bronchodilators in eight healthy adult volunteers. In the Phase 2a part, 16 adults with moderate-to-severe COPD were randomly assigned to three nebulized treatments in rotating order: AERO-007 at a lower dose (100/50 micrograms), AERO-007 at a higher dose (200/100 micrograms), and a placebo. Washout periods were included between cycles to clear prior treatment from the body.
The study’s main goals were to assess the therapy’s movement into, through, and out of the body, as well as changes in lung function as measured by FEV1 (the amount of air a person can forcefully exhale in 1 second) over 24 hours after dosing.
These data strengthen our confidence in AERO-007 as a potential first-line maintenance, once-daily [LABA plus LAMA] bronchodilator therapy for COPD patients who need or prefer nebulized treatment.
Data showed that both doses of AERO-007 led to significant improvements in lung function compared with the placebo. The average FEV1 over a full day was 251 mL higher with the low dose and 262 mL higher with the high dose than with the placebo. Maximum FEV1 improvement was 311 mL for the lower dose and 302 mL for the higher dose relative to the placebo.
“Nebulized AERO-007 demonstrated rapid, clinically meaningful bronchodilation that was sustained over 24 hours, supporting the potential of a once-daily nebulized [LABA plus LAMA] fixed-dose combination approach for patients who may not receive the full benefit of handheld inhaler-based treatment,” Singh said.
Blood levels of both drugs in AERO-007 were similar to or lower than those reported with Utibron Neohaler, a COPD-approved dry powder inhaler containing indacaterol and glycopyrrolate.
Both doses of AERO-007 were well tolerated. Most adverse events were mild, and no patient discontinued treatment because of them.
“These data strengthen our confidence in AERO-007 as a potential first-line maintenance, once-daily [LABA plus LAMA] bronchodilator therapy for COPD patients who need or prefer nebulized treatment,” Tutuncu said. “I am grateful to the patients, investigators, advisors, and AeroRx team who made this study possible, and we look forward to advancing the program into the next stage of clinical development.”
Cindy Bowman
I currently take Breztri. It does not last 12 hours as I always have to use my rescue inhaler. I wish something would come along to keep my breathing steady all day. I use a spacer and clean the MDI (without the med) weekly.
I know it’s a long way off, and maybe impossible, but I would love to see stem cell treatment.
Margie Shaffer
I have been on oxygen for 12 years. Always looking for something new.
Dan Krauth
My COPD has progressed to the point to where nebulizer treatments with Budesonide and Arformoterol only bring relief for about 6 hours. Albuterol lasts about 3 hours. My next step is to be evaluated for biologics like Dupixent or Nucala. I note you do not include Guiafenisen or Erdosteine for mucus control during exacerbations. None of the bronchodilators are very effective when the lungs are coated with excess mucus.
Annette Kohls
This news is very exciting. I’m 85 and I’ve had COPD for many many many years. I also have nerve damage in my ribs from an open lung biopsy some years ago. So when I inhale the powdered dose, it’s hard to get a full inhale because of the pain. I would love something like this. Hope it achieves FTA approval. Good luck.
Terri Carson
I have used two different broncodialators Anoro and Stiolto, neither has opened me up very well. Rescue inhaler do nothing for me. I have never tried a nebulizer. This new medication sounds promising, can’t wait to try it.
Richard W Lyda
I am currently on Oxygen 24/7
Lee Reck
COPD Patients need all the HELP that they can get. Best of Luck to all.
KRISTINA MACPHAIL
When will this aero 007 be available please
g Kirk Finch II
I’m trying to get zephyr valves but can’t until I get the lobes sealed from asthma (treatment now in trial).
Judith Chumas
I use a nebuizer for the Arformoterol and Budesonide. Are these the best combination for my COPD and is the Incruse Ellipta a correct medication to be used with the other two? I was on Spiriva Handheld until it was discontiued . That was when I started the Incruse, Thank you very much for your input.
Mary Ingram
This is an exciting time for those of us with COPD who find it hard to use inhalers. My question is: what about those of us on triple medication inhalers such as Trelegy? Will this new medication in this study be able to add a steroid to the med combination?
Art
Has this been approved for use inCanada ?
Richard Lyda
Would like to try the formulated medications that are currently in trial 4
I am 81 in good health with the exception of my lungs
Hope Powers
I suffer from COPD with asthma overlap. On 3 liters oxygen 24/7. I am 78 yoa ,male.
Christine Douglas
I would love for this information to be passed onto Dr. Patricia Wade and Dr. Jennifer Romero. I also would like to get off some of my meds, but have a better lung function. My best Peak Flow is 270 and I feel good. I think I am compenstated.
Louis Tracy
I am interested in participating in the next stage of clinical development. Can you help me get involved in this. thank you
Cindy Freeman
How can I join a trial?
Alizamin Sadigov
Significant part of patients with COPD who are suffered from hyperinflation with markedly dyspnoea may benefit fro dual bronchodilation And use of dual bronchodilation combination once daily is great approach to the patient comfort whcihc is most important for us.
Mike Slaybaugh
I would like to try this med as i'm in the later stages of COPD!!! Please send info to my email.
Pam Isla
Are there any significant trials underway with stem cells?
Sheila templin
I’m am currently not doing well and would welcome any thing new or different
Alizaman Sadigov
We also hope that LAMA/LABA combination through Nebulayzer will associated with reduced exacerbation of the disease
Marise Cheney
I am also on Bricanyl & Trimbow 200/6/10
I suffer severe breathlessness.
Marise Cheney
I am also on Bricanyl & Trimbow 200/6/10
I suffer severe breathlessness.
Richard w Lyda
I believe taking medicine for COPD through the Medulizer helps get the meds to the lungs more quickly
I am looking forward to the new blended nebulizer. I am on oxygen 24/7 and would like help to reduce this requirement
Maria Giles
Have severe COPD and am on Trimbo and salbutamol lnhalors which do nothing for me. Breathing is bad all the time and am very limited as to what I can do. Have never had a nebuliser but would love to try one to see if it would help me
Karen Shandor
How does Trelegy inhaler compare with AERO007 in boosting lung function?
N Weiss
How do I get this product or join a clinical trial?
Tim Williams
I am 83 years old, and was diagnosed w/mild to severe COPD in 2017. I have been under a Pulmonologists care since then. I was in the hospital last Oct.2025 for 4 days with (1st time) Covid 19. (this seemed to double all my symptoms for all my ailments.) I also spent another 4 days in the hospital in June 2026 for Pneumonia, but it took weeks to totally get rid of it. I religiously walk my 20 Lb. dog every day for at least a half mile at the park, They have numerous benches to sit, and I walk 200 ft. and sit. walk 200 & sit. Do you think this might help me, if so, when will it be available?
Anthony Mcgill
IGood day....is there a timescale where this could become available.My wife desperately needs help.Sdhes 69 and otherwise healthy,but emphysema is ruining her life....Best regards...Anthony McGill
Fran
This newsletter was jammed packed of promising hope! I am going to send it to my Pulmonologist. Not sure if she has the time to add Copdnewstudy o her reading list, but I always like to discuss clinical trials and what coming down the pipeline. This newsletter is where I’d heard about Daliresp and Duprixent.
What a way to finish off my already great feeling day☺️