COPDPhase 2AERODUO-2NCT07896252
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
A Phase 2 study testing AERO-001, AERO-002 and AERO-007 in people with COPD and Chronic Obstructive Pulmonary Disease (COPD), run by AeroRx Therapeutics Inc. at 2 sites in United Kingdom.
Trial summary
This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Lung Disease Chronic
- What is being tested?
- AERO-001, AERO-002 and AERO-007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 40 to 75 years, inclusive, at the time of informed consent
- Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Report, 2026 for at least 12 months prior to Screening Visit 1
- Post-bronchodilator spirometry (after 10 to 30 minutes following 4 puffs of albuterol via MDI with a spacer) at Screening Visit 2 demonstrating the following:
- FEV1 > 40 and < 80% of predicted normal (using the Global Lung Function Initiative [GLI] 2012 reference values)
- FEV1/forced vital capacity (FVC) ratio < 0.70
- ≥ 150 mL increase from pre-bronchodilator FEV1 following 4 puffs of albuterol
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- Ability to change current COPD therapy and discontinue long-acting bronchodilators, if applicable, for the duration of the trial and short-acting bronchodilators for 8 hours prior to dosing at each Treatment Visit
- Current or former-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, 10 packs/day for 1 year)
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
- Female participants of childbearing potential must not be pregnant, breast feeding or lactating and heterosexual female participants of childbearing potential must agree to use, with their partner, a male condom plus an approved method of highly effective birth control from the time of informed consent and for 30 days following the last administered dose
- Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening Visit 1 and a negative urine pregnancy test prior to dosing at each Treatment Visit
- Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following the last administered dose
- Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days following the last administered dose
- Willing and able to provide written informed consent
Who cannot join
- Current evidence or recent history of significant comorbidities; including cardiovascular disease (such as myocardial infarction, cardiac failure, uncontrolled hypertension, or life-threatening arrhythmias), uncontrolled diabetes, neurologic, psychiatric, hepatic, renal, immunological, or hematological conditions within the last 6 months prior to Screening Visit 1
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) type 1 and/or 2 antibodies at Screening Visit 1
- Lower respiratory tract infection within 6 weeks prior to Screening Visit 1
- Recent history of hospitalization due to an exacerbation of airway disease or acute worsening of COPD requiring antibiotic or systemic corticosteroid treatment within 6 months prior to Screening Visit 1
- Other respiratory disorders: Current diagnosis of predominant asthma, lung cancer, bronchiectasis, interstitial lung disease, tuberculosis, pulmonary hypertension, or other non-specific pulmonary diseases
- Prior lung volume reduction surgery or history of chest/lung irradiation
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- Daily oxygen therapy for > 12 hours per day
- Body mass index >35 kg/m2
- Abnormal and clinically significant 12-lead ECG findings at Screening Visit 1
- Current or recent history of medical conditions that are contraindicated for use of an inhaled LAMA (such as urinary retention or bladder neck obstruction type symptoms, prostatic hypertrophy, or narrow-angle glaucoma) within the last 6 months prior to Screening Visit 1
- Current or recent history (previous 12 months) of excessive use or abuse of alcohol (males >21 units per week and females >14 units per week)
- Current evidence or history (within the past 2 years) of abusing legal drugs or use of illegal drugs or substances
- Donation of 450 mL of blood within 8 weeks of Screening Visit 1
- Major surgery (requiring general anaesthesia) within 6 weeks prior to Screening Visit 1, or planned surgery through the EOS Visit
- History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to Screening Visit 1
- History of intolerance or hypersensitivity to any of the ingredients in the formulation for AERO-001, AERO-002, AERO-007, or other aerosol medications
- Participation in another investigational drug trial within 30 days of the last dose, 5 half-lives or twice the duration of the biological effect, whichever is longer, prior to Screening Visit 1
- History or high risk of noncompliance with trial visits and procedures or unsuitable for entry into the trial at the discretion of the Investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Parexel
London
- Recruiting
Medicines Evaluation Unit
Manchester
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, 14-Day Treatment, 2-Period Crossover Trial Evaluating the Lung Function Response After Treatment With Inhaled LABA and LAMA Monotherapies and Their Combination AERO-007 Administered Via Nebulization in Participants With Chronic Obstructive Pulmonary Disease (COPD) (AERODUO-2 Trial)
This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD).
Read the detailed description
Combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial therapy for patients with chronic obstructive pulmonary disease (COPD). Although there are currently multiple LABA+LAMA combination bronchodilators available in metered dose inhalers (MDIs), dry powder inhalers (DPI), and soft mist inhalers (SMI), a significant percentage of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers.
Nebulized delivery provides an effective alternative where disease management is sub optimal. To date there are no approved LABA+LAMA combinations available by nebulization.
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) for delivery in a general purpose nebulizer device. A phase 2a, single-dose, dose-ranging study of AERO-007 has been completed in participants with COPD at two dose levels (100/50 µg and 200/100 µg). AERO-007 at both low and high doses was well tolerated with robust, clinically meaningful and statistically significant bronchodilation with rapid onset of action that was sustained for 24 hours.
The objective of this phase 2b study is to determine the optimal doses of the monotherapy components of AERO-007 and to assess the safety, PK and bronchodilation profile of AERO-007 following 14 days of dosing in participants with COPD.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Lung Disease Chronic, Lung Diseases, Obstructive
- Being tested
- AERO-001, AERO-002, AERO-007
- Keywords
- COPD, LABA+LAMA, Inhalation, Nebulization, General purpose nebulizer, Bronchodilation, FEV1, Pharmacokinetics, Phase 2b, Safety, Efficacy, Randomized, Double-blind, Placebo-controlled, 2-period crossover, Indacaterol, Glaycopyrrolate, LABA, LAMA, AeroRx
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERO-001Drug
Double-blind
AERO-002Drug
Double-blind
AERO-007Drug
Double-blind
| Study group | Role | What they receive |
|---|---|---|
| AERO-001 low dose | Experimental | Not described Receives: Drug: AERO-001 |
| AERO-001 medium dose | Experimental | Not described Receives: Drug: AERO-001 |
| AERO-001 high dose | Experimental | Not described Receives: Drug: AERO-001 |
| AERO-002 low dose | Experimental | Not described Receives: Drug: AERO-002 |
| AERO-002 medium dose | Experimental | Not described Receives: Drug: AERO-002 |
| AERO-002 high dose | Experimental | Not described Receives: Drug: AERO-002 |
| AERO-007 | Experimental | Not described Receives: Drug: AERO-007 |
| Placebo | Placebo comparator | Not described Receives: Drug: AERO-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchodilation - FEV1
Measured: Change from baseline in FEV1 at 24 hours post-dose on Days 1 and 14
Bronchodilation - FEV AUC
Measured: Change from baseline in FEV1 AUC(0-24 hours) on Days 1 and 14
Bronchodilation - Peak FEV1
Measured: Peak change in FEV1 within 4 hours post-dose on Days 1 and 14
Bronchodilation - time to onset of FEV1 >100mL
Measured: Change in FEV1 >100mL from pre-dose on Days 1 and 14
Secondary outcomes (9)
Pharmacokinetics - Cmax
Cmax (maximum plasma concentration)
Measured: 0-24 hours on Days 1 and 14
Pharmacokinetics - AUC
AUC (area under the plasma concentration)
Measured: AUC(0-6 hours) on Days 1 and 14
Pharmacokinetics - Tmax
Tmax (time to maximum concentration)
Measured: Tmax on Days 1 and 14
Treatment-emergent adverse events (TEAEs)
Number of participants with TEAEs
Measured: Up to approximately Day 14
Blood Pressure
Number of participants with markedly abnormal changes in Blood Pressure
Measured: Up to approximately Day 14
Heart Rate
Number of participants with markedly abnormal changes in Heart Rate
Measured: Up to approximately Day 14
12-lead ECG - QT Interval corrected for Heart Rate Using Fridericia's Formula (QTcF)
Number of participants with markedly abnormal changes in QTcF
Measured: Up to approximately Day 14
Clinical laboratory - Hematology
Number of participants with markedly abnormal changes in hematology parameters
Measured: Up to approximately Day 14
Clinical laboratory - Blood Chemistry
Number of participants with markedly abnormal changes in blood chemistry parameters
Measured: Up to approximately Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AeroRx Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896252
- Sponsor's protocol ID
- AERO-007-02
- Other IDs
- 2026-527150-39
- Acronym
- AERODUO-2
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, 14-Day Treatment, 2-Period Crossover Trial Evaluating the Lung Function Response After Treatment With Inhaled LABA and LAMA Monotherapies and Their Combination AERO-007 Administered Via Nebulization in Participants With Chronic Obstructive Pulmonary Disease (COPD) (AERODUO-2 Trial)
- ClinicalTrials.gov ID
- NCT07896252
- Acronym / sponsor ID
- AERODUO-2 / AERO-007-02
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Lung Disease Chronic, Lung Diseases, Obstructive
- Keywords
- COPD, LABA+LAMA, Inhalation, Nebulization, General purpose nebulizer, Bronchodilation, FEV1, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AeroRx Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD).
Detailed description
Combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial therapy for patients with chronic obstructive pulmonary disease (COPD). Although there are currently multiple LABA+LAMA combination bronchodilators available in metered dose inhalers (MDIs), dry powder inhalers (DPI), and soft mist inhalers (SMI), a significant percentage of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers.
Nebulized delivery provides an effective alternative where disease management is sub optimal. To date there are no approved LABA+LAMA combinations available by nebulization.
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) for delivery in a general purpose nebulizer device. A phase 2a, single-dose, dose-ranging study of AERO-007 has been completed in participants with COPD at two dose levels (100/50 µg and 200/100 µg). AERO-007 at both low and high doses was well tolerated with robust, clinically meaningful and statistically significant bronchodilation with rapid onset of action that was sustained for 24 hours.
The objective of this phase 2b study is to determine the optimal doses of the monotherapy components of AERO-007 and to assess the safety, PK and bronchodilation profile of AERO-007 following 14 days of dosing in participants with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| AERO-001 low dose | Experimental | Drug: AERO-001 |
| AERO-001 medium dose | Experimental | Drug: AERO-001 |
| AERO-001 high dose | Experimental | Drug: AERO-001 |
| AERO-002 low dose | Experimental | Drug: AERO-002 |
| AERO-002 medium dose | Experimental | Drug: AERO-002 |
| AERO-002 high dose | Experimental | Drug: AERO-002 |
| AERO-007 | Experimental | Drug: AERO-007 |
| Placebo | Placebo comparator | Drug: AERO-007 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged 40 to 75 years, inclusive, at the time of informed consent
- Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Report, 2026 for at least 12 months prior to Screening Visit 1
- Post-bronchodilator spirometry (after 10 to 30 minutes following 4 puffs of albuterol via MDI with a spacer) at Screening Visit 2 demonstrating the following:
- Ability to change current COPD therapy and discontinue long-acting bronchodilators, if applicable, for the duration of the trial and short-acting bronchodilators for 8 hours prior to dosing at each Treatment Visit
- Current or former-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, 10 packs/day for 1 year)
Key exclusion criteria (18 listed)
- Current evidence or recent history of significant comorbidities; including cardiovascular disease (such as myocardial infarction, cardiac failure, uncontrolled hypertension, or life-threatening arrhythmias), uncontrolled diabetes, neurologic, psychiatric, hepatic, renal, immunological, or hematological conditions within the last 6 months prior to Screening Visit 1
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) type 1 and/or 2 antibodies at Screening Visit 1
- Lower respiratory tract infection within 6 weeks prior to Screening Visit 1
- Recent history of hospitalization due to an exacerbation of airway disease or acute worsening of COPD requiring antibiotic or systemic corticosteroid treatment within 6 months prior to Screening Visit 1
- Other respiratory disorders: Current diagnosis of predominant asthma, lung cancer, bronchiectasis, interstitial lung disease, tuberculosis, pulmonary hypertension, or other non-specific pulmonary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AERO-001Double-blind | Drug | AERO-001 high dose, AERO-001 low dose, AERO-001 medium dose |
| AERO-002Double-blind | Drug | AERO-002 high dose, AERO-002 low dose, AERO-002 medium dose |
| AERO-007Double-blind | Drug | AERO-007, Placebo |
Primary outcome
Bronchodilation - FEV1
Time frame: Change from baseline in FEV1 at 24 hours post-dose on Days 1 and 14
Bronchodilation - FEV AUC
Time frame: Change from baseline in FEV1 AUC(0-24 hours) on Days 1 and 14
Bronchodilation - Peak FEV1
Time frame: Peak change in FEV1 within 4 hours post-dose on Days 1 and 14
Bronchodilation - time to onset of FEV1 >100mL
Time frame: Change in FEV1 >100mL from pre-dose on Days 1 and 14
9 secondary outcomes
Pharmacokinetics - Cmax
Time frame: 0-24 hours on Days 1 and 14
Pharmacokinetics - AUC
Time frame: AUC(0-6 hours) on Days 1 and 14
Pharmacokinetics - Tmax
Time frame: Tmax on Days 1 and 14
Treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately Day 14
Blood Pressure
Time frame: Up to approximately Day 14
Heart Rate
Time frame: Up to approximately Day 14
12-lead ECG - QT Interval corrected for Heart Rate Using Fridericia's Formula (QTcF)
Time frame: Up to approximately Day 14
Clinical laboratory - Hematology
Time frame: Up to approximately Day 14
Clinical laboratory - Blood Chemistry
Time frame: Up to approximately Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AERO-001, AERO-002 and AERO-007 in people with COPD and Chronic Obstructive Pulmonary Disease (COPD), run by AeroRx Therapeutics Inc. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director Medical Director (+1-858-750-4717, info@aerorxtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchodilation - FEV1 (time frame: Change from baseline in FEV1 at 24 hours post-dose on Days 1 and 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.