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AsthmaPhase 2LevanteNCT06529419

A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

A Phase 2 study testing AZD8630 and Inhaler in people with Asthma, run by AstraZeneca at 196 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Asthma
What is being tested?
AZD8630 and Inhaler
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
537 participants
Where
196 sitesin 23 countries
Study dates
30 Aug 2024to 4 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Principal inclusion criteria (abbreviated):

  1. Patient must be 18 to 80 years of age inclusive
  2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years
  3. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)
  4. Pre-BD FEV1 ≥ 40%
  5. A history of asthma exacerbations within the last 12 months
  6. \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.
  7. BMI within the range 18-37 kg/m2 (inclusive)
  8. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.
  9. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.
  10. Capable of giving signed informed consent.

Principal exclusion criteria (abbreviated):

  1. History of life-threatening asthma
  2. Recently completed treatment for respiratory infection and/or asthma exacerbation
  3. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
  4. Any disorder that is not stable in the opinion of the Investigator and could:
  5. Affect the safety of the patient throughout the study
  6. Influence the findings of the study or their interpretation
  7. Impede the patient's ability to complete the entire duration of study
  8. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
  9. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
  10. Patients with history of HIV infection or who test positive for HIV.
  11. Congenital long QT syndrome or prolonged QTcF > 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
  12. Current untreated or uncontrolled arrhythmia.
  13. Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.
  14. A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.
  15. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months ago.
  16. Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study.
  17. Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years.
  18. Any other clinically relevant abnormal findings that in the opinion of the Investigator or medical monitor might compromise the safety of the patient in the study or interfere with evaluation of the study intervention.
  19. Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives.
  20. Treatment with Systemic steroids within 4 weeks.
  21. Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).

Trial locations and contacts

196 sites in 23 countries.

196 sites in 23 countries

United States45 sites
  • Research Site

    American Fork, Utah, 84003

  • Research Site

    Ames, Iowa, 50010

  • Research Site

    Ann Arbor, Michigan, 48109

  • Research Site

    Austin, Texas, 78704

  • Research Site

    Baltimore, Maryland, 21237

  • Research Site

    Beavercreek, Ohio, 45431

  • Research Site

    Chicago, Illinois, 60616

  • Research Site

    DeBary, Florida, 32713

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Greenville, North Carolina, 27834

  • Research Site

    Hampton, Virginia, 23666

  • Research Site

    Horsham, Pennsylvania, 19044

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Jensen Beach, Florida, 34957

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    La Mesa, California, 91942

  • Research Site

    Laguna Niguel, California, 92677

  • Research Site

    Lancaster, California, 93534

  • Research Site

    Largo, Florida, 33777

  • Research Site

    Las Vegas, Nevada, 89102

  • Research Site

    Las Vegas, Nevada, 89119

  • Research Site

    Lilburn, Georgia, 30047

  • Research Site

    Lima, Ohio, 45801

  • Research Site

    Long Beach, California, 90815

  • Research Site

    McKinney, Texas, 75069

  • Research Site

    Mesa, Arizona, 85213

  • Research Site

    Mesquite, Texas, 75149

  • Research Site

    Methuen, Massachusetts, 01844

  • Research Site

    Miami, Florida, 33135

  • Research Site

    Miami Lakes, Florida, 33014

  • Research Site

    Middletown, New York, 10941

  • Research Site

    Milwaukee, Wisconsin, 53228

  • Research Site

    New Haven, Connecticut, 06510

  • Research Site

    Oklahoma City, Oklahoma, 73120

  • Research Site

    Pearland, Texas, 77584

  • Research Site

    Riverdale, New Jersey, 07457

  • Research Site

    Roy, Utah, 84067

  • Research Site

    Salt Lake City, Utah, 84124

  • Research Site

    San Antonio, Texas, 78215

  • Research Site

    San Jose, California, 95117

  • Research Site

    Savannah, Georgia, 31406

  • Research Site

    Tampa, Florida, 33607

  • Research Site

    Winfield, Illinois, 60190

  • Research Site

    Winston-Salem, North Carolina, 27104

Other trials in United States

China19 sites
  • Research Site

    Baotou, 014010

  • Research Site

    Changchun, 130021

  • Research Site

    Chengdu, 610078

  • Research Site

    Chongqing, 401320

  • Research Site

    Guangzhou, 510163

  • Research Site

    Guiyang, 510630

  • Research Site

    Hefei, 230061

  • Research Site

    Hohhot, 010010

  • Research Site

    Jinan, 250021

  • Research Site

    Lanzhou, 730000

  • Research Site

    Nanchang, 330006

  • Research Site

    Ningbo, 315010

  • Research Site

    Qingdao, 266011

  • Research Site

    Shanghai, 200080

  • Research Site

    Shenyang, 110004

  • Research Site

    Shijiazhuang, 050051

  • Research Site

    Taiyuan, 030032

  • Research Site

    Wenzhou, 325027

  • Research Site

    Xuzhou, 221000

Other trials in China

Japan18 sites
  • Research Site

    Chūōku, 104-0031

  • Research Site

    Fukuoka, 819-8555

  • Research Site

    Hiratsuka-shi, 254-8502

  • Research Site

    Hiroshima, 730-0013

  • Research Site

    Kitakyushu, 802-0052

  • Research Site

    Kusatsu-shi, 525-8585

  • Research Site

    Maebashi, 371-0048

  • Research Site

    Maebashi, 371-0054

  • Research Site

    Meguro-ku, 153-8515

  • Research Site

    Mizunami-shi, 509-6134

  • Research Site

    Nankoku-shi, 783-8509

  • Research Site

    Niigata, 950-1197

  • Research Site

    Sakaishi, 591-8555

  • Research Site

    Sapporo, 064-0804

  • Research Site

    Shinjuku-ku, 162-8655

  • Research Site

    Toyoake-shi, 470-1192

  • Research Site

    Yanagawa-shi, 832-0059

  • Research Site

    Yokohama, 236-0037

Other trials in Japan

Ukraine11 sites
  • Research Site

    Chernivtsі, 58002

  • Research Site

    Ivano-Frankivsk, 76018

  • Research Site

    Ivano-Frankivsk, 76019

  • Research Site

    Kyiv, 02002

  • Research Site

    Kyiv, 02081

  • Research Site

    Kyiv, 03037

  • Research Site

    Kyiv, 03049

  • Research Site

    Kyiv, 03680

  • Research Site

    Lutsk, 43000

  • Research Site

    Uzhhorod, 88018

  • Research Site

    Vinnytsia, 21029

Other trials in Ukraine

Argentina9 sites
  • Research Site

    Alberdi, X5033DCE

  • Research Site

    CABA, C1426

  • Research Site

    Capital Federal, C1060ABN

  • Research Site

    Mar del Plata, 7600

  • Research Site

    Quilmes, B1878FNR

  • Research Site

    Rosario, 2000

  • Research Site

    San Fernando, B1646EBJ

  • Research Site

    San Juan Bautista, 1888

  • Research Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Czechia8 sites
  • Research Site

    Brno, 62500

  • Research Site

    Hradec Králové, 50005

  • Research Site

    Jindřichův Hradec, 377 01

  • Research Site

    Kralupy nad Vltavou, 278 01

  • Research Site

    Pilsen, 32300

  • Research Site

    Prague, 15300

  • Research Site

    Teplice, 415 01

  • Research Site

    Varnsdorf, 407 47

Other trials in Czechia

Germany8 sites
  • Research Site

    Berlin, 10119

  • Research Site

    Bonn, 53127

  • Research Site

    Essen, 45239

  • Research Site

    Frankfurt, 60596

  • Research Site

    Landsberg, 86899

  • Research Site

    Leipzig, 04207

  • Research Site

    Mainz, 55128

  • Research Site

    Marburg, 35037

Other trials in Germany

Spain8 sites
  • Research Site

    Barcelona, 8035

  • Research Site

    Benalmádena, 29631

  • Research Site

    Madrid, 28041

  • Research Site

    Majadahonda, 28222

  • Research Site

    Málaga, 29010

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Santander, 39008

  • Research Site

    Valencia, 46010

Other trials in Spain

Slovakia7 sites
  • Research Site

    Kežmarok, 060 01

  • Research Site

    Košice, 04022

  • Research Site

    Levice, 93401

  • Research Site

    Prešov, 081 81

  • Research Site

    Topoľčany, 955 01

  • Research Site

    Topoľčany, 95501

  • Research Site

    Žilina, 010 01

Other trials in Slovakia

Taiwan7 sites
  • Research Site

    Kaohsiung City, 80756

  • Research Site

    Taichung, 40705

  • Research Site

    Taichung, 433004

  • Research Site

    Taipei, 0116

  • Research Site

    Taipei, 100

  • Research Site

    Taipei, 110

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Chile6 sites
  • Research Site

    Chile, 7770484

  • Research Site

    Curicó, 3341643

  • Research Site

    Santiago, 7500587

  • Research Site

    Santiago, 7500691

  • Research Site

    Talca, 3465584

  • Research Site

    Viña del Mar, 2540488

Other trials in Chile

Denmark6 sites
  • Research Site

    Aalborg, 9100

  • Research Site

    Hvidovre, 2650

  • Research Site

    København NV, 2400

  • Research Site

    Odense, 5000

  • Research Site

    Roskilde, 4000

  • Research Site

    Vejle, 7100

Other trials in Denmark

South Africa6 sites
  • Research Site

    Cape Town, 7700

  • Research Site

    Durban, 4001

  • Research Site

    eMkhomazi, 4170

  • Research Site

    Observatory, 7925

  • Research Site

    Somerset West, 7130

  • Research Site

    Tygervalley, 7530

Other trials in South Africa

Turkey (Türkiye)6 sites
  • Research Site

    Adana, 1330

  • Research Site

    Altındağ-Ankara, 06230

  • Research Site

    Ankara

  • Research Site

    Istanbul, 34854

  • Research Site

    Kirikkale, 71450

  • Research Site

    Mersin, 33079

Other trials in Turkey (Türkiye)

France5 sites
  • Research Site

    Lyon, 69317

  • Research Site

    Marseille, 13915

  • Research Site

    Nice, F-06002

  • Research Site

    Paris, 75018

  • Research Site

    Reims, 51092

Other trials in France

Mexico5 sites
  • Research Site

    Durango, 34200

  • Research Site

    Guadalajara, 44130

  • Research Site

    Monterrey, 64040

  • Research Site

    Monterrey, 64710

  • Research Site

    Villahermosa, 86035

Other trials in Mexico

South Korea5 sites
  • Research Site

    Daegu, 42415

  • Research Site

    Seoul, 03312

  • Research Site

    Seoul, 06591

  • Research Site

    Seoul, 3722

  • Research Site

    Seoul, 5505

Other trials in South Korea

Israel4 sites
  • Research Site

    Ashkelon, 78278

  • Research Site

    Jerusalem, 9372212

  • Research Site

    Rehovot, 76100

  • Research Site

    Tel Aviv, 6423906

Other trials in Israel

Italy4 sites
  • Research Site

    Genoa, 16132

  • Research Site

    Milan, 20122

  • Research Site

    Roma, 00168

  • Research Site

    Roma, 161

Other trials in Italy

Belgium3 sites
  • Research Site

    Duffel, 2570

  • Research Site

    Mechelen, 2800

  • Research Site

    Namur, 5101

Other trials in Belgium

United Kingdom3 sites
  • Research Site

    Bradford, BD9 6RJ

  • Research Site

    Liverpool, L7 8XP

  • Research Site

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Netherlands2 sites
  • Research Site

    Alkmaar, 1815 JD

  • Research Site

    Amersfoort, 3813 TZ

Other trials in Netherlands

Hong Kong1 site
  • Research Site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

Read the detailed description

This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks.

This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally

Conditions
Asthma
Being tested
AZD8630, Placebo, Inhaler
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD8630Drug

    The drug will be administered by inhalation

  • PlaceboDrug

    The placebo will be administered by inhalation

  • InhalerDevice

    The drug/placebo will be administered by inhalation using the inhaler

Study groups in NCT06529419
Study groupRoleWhat they receive
AZD8630 dose AExperimentalInhaled AZD8630 administered at a dose A
Receives: Drug: AZD8630; Device: Inhaler
AZD8630 dose BExperimentalInhaled AZD8630 administered at a dose B
Receives: Drug: AZD8630; Device: Inhaler
AZD8630 dose CExperimentalInhaled AZD8630 administered at a dose C
Receives: Drug: AZD8630; Device: Inhaler
PlaceboPlacebo comparatorInhaled placebo
Receives: Drug: Placebo; Device: Inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first CompEx Asthma event

    The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables:

    • PEF
    • Asthma symptom score (0 to 3)
    • Use of rescue medication

    Measured: 12 weeks

Secondary outcomes (5)
  1. Pre-BD FEV1

    Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.

    Measured: 12 weeks

  2. ACQ-6:

    Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6). The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease

    Measured: 12 weeks

  3. AQLQ12+

    Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains

    Measured: 12 weeks

  4. SGRQ

    Change from baseline in the St. George's Respiratory Questionnaire. The SGRQ includes 50 questions grouped into two parts: Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.

    Measured: 12 weeks

  5. FeNO

    Change from baseline to: FeNO: Weeks 1, 2, 4, 8, and 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start30 Aug 2024
  3. Primary completion4 Feb 2026
  4. Study completion4 Feb 2026

Resources

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
Parallel groups
Model description
This is a parallel-group treatment study with 4 arms that is patient and Investigator blinded. Patients will be randomly assigned in a 1:1:1:1 ratio to one of the 4 treatment arms.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529419
Sponsor's protocol ID
D6830C00003
Acronym
Levante
Status last verified
Feb 2026
First submitted
15 Jul 2024
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD8630 and Inhaler in people with Asthma, run by AstraZeneca at 196 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in United States, China, Japan, Ukraine, Argentina and 18 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first CompEx Asthma event (time frame: 12 weeks). 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 2 Mar 2026.

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