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

NCT06529419 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: D6830C00003
• Study Type: interventional
• Target: 537
• Locations: 23 countries
• Sites: 196

Brief 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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (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

  12 weeks

Secondary Outcomes (5)

• Pre-BD FEV1

  12 weeks

• ACQ-6:

  12 weeks

• AQLQ12+

  12 weeks

• SGRQ

  12 weeks

• FeNO

  12 weeks

Study Arms (4)

AZD8630 dose A

EXPERIMENTAL

Inhaled AZD8630 administered at a dose A

Drug: AZD8630; Device: Inhaler

AZD8630 dose B

EXPERIMENTAL

Inhaled AZD8630 administered at a dose B

Drug: AZD8630; Device: Inhaler

AZD8630 dose C

EXPERIMENTAL

Inhaled AZD8630 administered at a dose C

Drug: AZD8630; Device: Inhaler

Placebo

PLACEBO COMPARATOR

Inhaled placebo

Drug: Placebo; Device: Inhaler

Interventions

AZD8630 DRUG

The drug will be administered by inhalation

AZD8630 dose A; AZD8630 dose B; AZD8630 dose C

Placebo DRUG

The placebo will be administered by inhalation

Placebo

Inhaler DEVICE

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

AZD8630 dose A; AZD8630 dose B; AZD8630 dose C; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 to 80 years of age inclusive
• 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
• \. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)
• \. Pre-BD FEV1 ≥ 40%
• \. A history of asthma exacerbations within the last 12 months
• \. \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.
• \. BMI within the range 18-37 kg/m2 (inclusive)
• \. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.
• \. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.
• \. Capable of giving signed informed consent.

You may not qualify if:

• History of life-threatening asthma
• Recently completed treatment for respiratory infection and/or asthma exacerbation
• Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
• Any disorder that is not stable in the opinion of the Investigator and could:
• Affect the safety of the patient throughout the study
• Influence the findings of the study or their interpretation
• Impede the patient's ability to complete the entire duration of study
• Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
• Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
• Patients with history of HIV infection or who test positive for HIV.
• Congenital long QT syndrome or prolonged QTcF \> 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
• Current untreated or uncontrolled arrhythmia.
• Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.
• A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.
• Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months ago.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (196)

Research Site

Mesa, Arizona, 85213, United States

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Huntington Beach, California, 92647, United States

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La Mesa, California, 91942, United States

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Laguna Niguel, California, 92677, United States

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Lancaster, California, 93534, United States

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Long Beach, California, 90815, United States

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San Jose, California, 95117, United States

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New Haven, Connecticut, 06510, United States

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DeBary, Florida, 32713, United States

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Jacksonville, Florida, 32216, United States

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Jensen Beach, Florida, 34957, United States

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Largo, Florida, 33777, United States

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Miami, Florida, 33135, United States

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Miami Lakes, Florida, 33014, United States

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Tampa, Florida, 33607, United States

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Lilburn, Georgia, 30047, United States

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Savannah, Georgia, 31406, United States

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Chicago, Illinois, 60616, United States

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Winfield, Illinois, 60190, United States

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Ames, Iowa, 50010, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21237, United States

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Methuen, Massachusetts, 01844, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48202, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89119, United States

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Riverdale, New Jersey, 07457, United States

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Middletown, New York, 10941, United States

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Greenville, North Carolina, 27834, United States

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Winston-Salem, North Carolina, 27104, United States

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Beavercreek, Ohio, 45431, United States

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Lima, Ohio, 45801, United States

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Oklahoma City, Oklahoma, 73120, United States

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Horsham, Pennsylvania, 19044, United States

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Austin, Texas, 78704, United States

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McKinney, Texas, 75069, United States

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Mesquite, Texas, 75149, United States

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Pearland, Texas, 77584, United States

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San Antonio, Texas, 78215, United States

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American Fork, Utah, 84003, United States

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Roy, Utah, 84067, United States

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Salt Lake City, Utah, 84124, United States

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Hampton, Virginia, 23666, United States

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Milwaukee, Wisconsin, 53228, United States

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Alberdi, X5033DCE, Argentina

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CABA, C1426, Argentina

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Capital Federal, C1060ABN, Argentina

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Mar del Plata, 7600, Argentina

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Quilmes, B1878FNR, Argentina

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Rosario, 2000, Argentina

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San Fernando, B1646EBJ, Argentina

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San Juan Bautista, 1888, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Duffel, 2570, Belgium

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Mechelen, 2800, Belgium

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Namur, 5101, Belgium

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Chile, 7770484, Chile

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Curicó, 3341643, Chile

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Santiago, 7500587, Chile

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Santiago, 7500691, Chile

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Talca, 3465584, Chile

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Viña del Mar, 2540488, Chile

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Baotou, 014010, China

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Changchun, 130021, China

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Chengdu, 610078, China

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Chongqing, 401320, China

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Guangzhou, 510163, China

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Guiyang, 510630, China

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Hefei, 230061, China

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Hohhot, 010010, China

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Jinan, 250021, China

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Lanzhou, 730000, China

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Nanchang, 330006, China

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Ningbo, 315010, China

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Qingdao, 266011, China

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Shanghai, 200080, China

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Shenyang, 110004, China

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Shijiazhuang, 050051, China

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Taiyuan, 030032, China

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Wenzhou, 325027, China

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Xuzhou, 221000, China

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Brno, 62500, Czechia

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Hradec Králové, 50005, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Pilsen, 32300, Czechia

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Prague, 15300, Czechia

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Teplice, 415 01, Czechia

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Varnsdorf, 407 47, Czechia

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Aalborg, 9100, Denmark

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Hvidovre, 2650, Denmark

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København NV, 2400, Denmark

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Odense, 5000, Denmark

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Roskilde, 4000, Denmark

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Vejle, 7100, Denmark

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Lyon, 69317, France

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Marseille, 13915, France

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Nice, F-06002, France

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Paris, 75018, France

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Reims, 51092, France

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Berlin, 10119, Germany

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Bonn, 53127, Germany

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Essen, 45239, Germany

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Frankfurt, 60596, Germany

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Landsberg, 86899, Germany

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Leipzig, 04207, Germany

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Mainz, 55128, Germany

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Marburg, 35037, Germany

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Hong Kong, Hong Kong

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Ashkelon, 78278, Israel

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Jerusalem, 9372212, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 6423906, Israel

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Genoa, 16132, Italy

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Milan, 20122, Italy

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Roma, 00168, Italy

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Roma, 161, Italy

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Chūōku, 104-0031, Japan

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Fukuoka, 819-8555, Japan

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Hiratsuka-shi, 254-8502, Japan

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Hiroshima, 730-0013, Japan

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Kitakyushu, 802-0052, Japan

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Kusatsu-shi, 525-8585, Japan

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Maebashi, 371-0048, Japan

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Maebashi, 371-0054, Japan

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Meguro-ku, 153-8515, Japan

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Mizunami-shi, 509-6134, Japan

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Nankoku-shi, 783-8509, Japan

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Niigata, 950-1197, Japan

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Sakaishi, 591-8555, Japan

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Sapporo, 064-0804, Japan

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Shinjuku-ku, 162-8655, Japan

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Toyoake-shi, 470-1192, Japan

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Yanagawa-shi, 832-0059, Japan

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Yokohama, 236-0037, Japan

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Durango, 34200, Mexico

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Guadalajara, 44130, Mexico

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Monterrey, 64040, Mexico

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Monterrey, 64710, Mexico

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Villahermosa, 86035, Mexico

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Alkmaar, 1815 JD, Netherlands

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Amersfoort, 3813 TZ, Netherlands

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Kežmarok, 060 01, Slovakia

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Košice, 04022, Slovakia

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Levice, 93401, Slovakia

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Prešov, 081 81, Slovakia

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Topoľčany, 955 01, Slovakia

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Topoľčany, 95501, Slovakia

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Žilina, 010 01, Slovakia

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Cape Town, 7700, South Africa

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Durban, 4001, South Africa

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eMkhomazi, 4170, South Africa

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Observatory, 7925, South Africa

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Somerset West, 7130, South Africa

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Tygervalley, 7530, South Africa

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Daegu, 42415, South Korea

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Seoul, 03312, South Korea

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Seoul, 06591, South Korea

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Seoul, 3722, South Korea

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Seoul, 5505, South Korea

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Barcelona, 8035, Spain

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Benalmádena, 29631, Spain

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Madrid, 28041, Spain

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Majadahonda, 28222, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 07010, Spain

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Santander, 39008, Spain

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Valencia, 46010, Spain

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Kaohsiung City, 80756, Taiwan

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Taichung, 40705, Taiwan

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Taichung, 433004, Taiwan

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Taipei, 0116, Taiwan

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Taipei, 100, Taiwan

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Taipei, 110, Taiwan

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Taoyuan District, 333, Taiwan

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Adana, 1330, Turkey (Türkiye)

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Altındağ-Ankara, 06230, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, 34854, Turkey (Türkiye)

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Kırıkkale, 71450, Turkey (Türkiye)

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Mersin, 33079, Turkey (Türkiye)

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Chernivtsі, 58002, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Ivano-Frankivsk, 76019, Ukraine

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Kyiv, 02002, Ukraine

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Kyiv, 02081, Ukraine

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Kyiv, 03037, Ukraine

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Kyiv, 03049, Ukraine

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Kyiv, 03680, Ukraine

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Lutsk, 43000, Ukraine

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Uzhhorod, 88018, Ukraine

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Vinnytsia, 21029, Ukraine

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Bradford, BD9 6RJ, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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MeSH Terms

Conditions

Asthma

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Njira Lugogo

  Univeristy of Michigan Hospital, Ann Arbor, MI, US

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 31, 2024
• Study Start: August 30, 2024
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

DE (8); CZ (8); BE (3); TU (6); DK (6); FR (5); CN (19); HK (1); IL (4); IT (4); CL (6); SL (7); ME (5); KR (5); JP (18); ES (8); NL (2); GB (3); TW (7); AR (9); UA (11); US (45); ZA (6)