The independent contribution of Pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis.
David Araújo, Michal Shteinberg, Stefano Aliberti...
https://pubmed.ncbi.nlm.nih.gov/29386336Actively Recruiting
Phase 2
Age: 12Years +
All Genders
ID07088926
A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0292 IV in Participants 12 Years and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Led by AstraZeneca · Updated on 2026-06-03
435
Participants Needed
185
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in patients aged 12 years and older with bronchiectasis who are chronically colonized with Pseudomonas Aeruginosa (PsA). This Phase IIb study focuses on patients with non-cystic fibrosis bronchiectasis (NCFBE) and a history of frequent pulmonary exacerbations due to chronic PsA colonization. It also includes an exploratory group of bronchiectasis patients with cystic fibrosis (CF) colonized with PsA to explore broader applicability. The study compares two doses of AZD0292 given by intravenous infusion starting on Day 1, followed by subsequent doses according to a schedule of assessments, against a placebo group receiving similar infusions. Participants are randomized into three groups: high-dose AZD0292, low-dose AZD0292, and placebo. Treatment continues throughout the study with multiple administrations as scheduled. Participants will be involved in regular monitoring including clinical assessments and laboratory tests to track lung function, quality of life, and safety outcomes. The primary outcome is the annualized rate of exacerbations over a follow-up period ranging from 28 to 52 weeks. Secondary measures include severe exacerbation rates, quality of life scores, time to first exacerbation, serum drug concentrations, immune response to the drug, and incidence of adverse events. Safety monitoring extends to 24 weeks after the final dose, with comprehensive evaluation throughout the study duration.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant must be 12 years of age or older at the time of informed consent/assent
- Weight of at least 35 kg
- Bronchiectasis diagnosis confirmed by CT scan showing abnormal bronchial dilation in one or more lobes
- History of two or more moderate exacerbations or at least one severe exacerbation requiring antibiotics in the past 12 months
- Clinically stable and free from bronchiectasis exacerbation for at least 4 weeks before randomization
- Pre- or post-bronchodilator FEV1 of 25% predicted value or higher at screening
- Positive test for Pseudomonas Aeruginosa in airway sample within last 24 months
- Positive sputum culture for Pseudomonas Aeruginosa within 5 weeks before randomization
- Able to provide signed informed consent or assent and comply with study requirements
You will not qualify if you...
- Primary lung diagnosis other than bronchiectasis
- Active tuberculosis or nontuberculous mycobacterial infection being treated or requiring treatment
- Active allergic bronchopulmonary aspergillosis being treated or requiring treatment
- Need for long-term supplemental oxygen (use for ambulation or breathlessness after exercise is allowed)
- Current or recent malignancy within 5 years except certain treated skin and cervical cancers
- AIDS or advanced HIV disease with low CD4 count
- History of severe allergic reaction to monoclonal antibodies
- Recent start (within 3 months) of long-term anti-Pseudomonas antibiotics, macrolides, or DPP-1 inhibitors
- Recent start (within 3 months) of chronic immunosuppressive therapy including steroids above 5 mg
- Use of investigational products for bronchiectasis exacerbations
- Recent start (within 3 months) of CFTR modulator therapy for cystic fibrosis patients
- Female participants who are pregnant, breastfeeding, or not using effective contraception or abstinence from 4 weeks before and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Minimum 28 weeks to maximum 52 weeks
Participants receive IV infusions of AZD0292 (high-dose or low-dose) or placebo according to the study schedule to prevent bronchiectasis exacerbations.
Multiple IV infusion visits per study schedule over the treatment period
Follow-up
Duration - Up to 24 weeks after the final dose
Participants are monitored for safety and efficacy outcomes after the last dose of study intervention, including adverse events and exacerbation rates.
Visits at specified timepoints up to 24 weeks after treatment ends
Trial Site Locations
Total: 185 locations
1
Research Site
Orange, California, United States, 92868
Actively Recruiting
2
Research Site
San Francisco, California, United States, 94143
Actively Recruiting
3
Research Site
Denver, Colorado, United States, 80206
Not Yet Recruiting
4
Research Site
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
5
Research Site
Jacksonville, Florida, United States, 32209
Actively Recruiting
6
Research Site
Miami Lakes, Florida, United States, 33014
Suspended
7
Research Site
Naples, Florida, United States, 34102
Actively Recruiting
8
Research Site
Ormond Beach, Florida, United States, 32174
Actively Recruiting
9
Research Site
Plantation, Florida, United States, 33324
Actively Recruiting
10
Research Site
Rincon, Georgia, United States, 31326
Actively Recruiting
11
Research Site
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
Research Site
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
13
Research Site
Detroit, Michigan, United States, 48202
Not Yet Recruiting
14
Research Site
Rochester, Minnesota, United States, 55905
Withdrawn
15
Research Site
St Louis, Missouri, United States, 63130
Actively Recruiting
16
Research Site
New York, New York, United States, 10016
Actively Recruiting
17
Research Site
New Bern, North Carolina, United States, 28562
Actively Recruiting
18
Research Site
Winston-Salem, North Carolina, United States, 27104
Not Yet Recruiting
19
Research Site
Tulsa, Oklahoma, United States, 74133
Withdrawn
20
Research Site
DuBois, Pennsylvania, United States, 15801
Withdrawn
21
Research Site
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
22
Research Site
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
23
Research Site
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
24
Research Site
Austin, Texas, United States, 78705
Withdrawn
25
Research Site
Mansfield, Texas, United States, 76063
Actively Recruiting
26
Research Site
Ciudad de Buenos Aires, Argentina, C1180AAX
Actively Recruiting
27
Research Site
Florida, Argentina, B1602DQD
Actively Recruiting
28
Research Site
Rosario, Argentina, 2000
Actively Recruiting
29
Research Site
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
30
Research Site
Birtinya, Australia, 4575
Not Yet Recruiting
31
Research Site
Macquarie University, Australia, 2109
Actively Recruiting
32
Research Site
South Brisbane, Australia, 4101
Actively Recruiting
33
Research Site
Ghent, Belgium, 9000
Actively Recruiting
34
Research Site
Leuven, Belgium, 3000
Actively Recruiting
35
Research Site
Liège, Belgium, 4000
Actively Recruiting
36
Research Site
Sint-Niklaas, Belgium, 9100
Actively Recruiting
37
Research Site
Blumenau, Brazil, 89030-101
Actively Recruiting
38
Research Site
Campinas, Brazil, 13060-080
Actively Recruiting
39
Research Site
Curitiba, Brazil, 80030-110
Actively Recruiting
40
Research Site
Curitiba, Brazil, 80230-130
Actively Recruiting
41
Research Site
Porto Alegre, Brazil, 9061-000
Actively Recruiting
42
Research Site
Porto Alegre, Brazil, 90630-165
Not Yet Recruiting
43
Research Site
Porto Alegre, Brazil, 91350-200
Not Yet Recruiting
44
Research Site
Salvador, Brazil, 40050-410
Withdrawn
45
Research Site
São José dos Campos, Brazil, 12230-001
Actively Recruiting
46
Research Site
São Paulo, Brazil, 05.403-010
Not Yet Recruiting
47
Research Site
São Paulo, Brazil, 05403-000
Actively Recruiting
48
Research Site
Calgary, Alberta, Canada, T2N4Z6
Actively Recruiting
49
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
50
Research Site
Ajax, Ontario, Canada, L1S 2J5
Actively Recruiting
51
Research Site
Stoney Creek, Ontario, Canada, L8G 2V6
Actively Recruiting
52
Research Site
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
53
Research Site
Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
Actively Recruiting
54
Research Site
Trois-Rivières, Quebec, Canada, G8T 7A1
Withdrawn
55
Research Site
Concepción, Chile, 4070196
Not Yet Recruiting
56
Research Site
Santiago, Chile, 8150000
Not Yet Recruiting
57
Research Site
Santiago, Chile, 8380453
Not Yet Recruiting
58
Research Site
Talca, Chile, 3481349
Not Yet Recruiting
59
Research Site
Viña del Mar, Chile, 2540364
Not Yet Recruiting
60
Research Site
Aalborg, Denmark, 9000
Actively Recruiting
61
Research Site
Aarhus N, Denmark, 8200
Withdrawn
62
Research Site
Hvidovre, Denmark, 2650
Actively Recruiting
63
Research Site
Odense C, Denmark, 5000
Actively Recruiting
64
Research Site
Roskilde, Denmark, 4000
Actively Recruiting
65
Research Site
Brest, France, 29200
Actively Recruiting
66
Research Site
Créteil, France, 94010
Actively Recruiting
67
Research Site
Marseille, France, 13915
Actively Recruiting
68
Research Site
Montpellier, France, 34295
Actively Recruiting
69
Research Site
Paris, France, 75014
Actively Recruiting
70
Research Site
Pessac, France, 33604
Actively Recruiting
71
Research Site
Strasbourg, France, 67091
Completed
72
Research Site
Toulouse, France, 31100
Actively Recruiting
73
Research Site
Berlin, Germany, 10117
Not Yet Recruiting
74
Research Site
Darmstadt, Germany, 64283
Withdrawn
75
Research Site
Essen, Germany, 45239
Actively Recruiting
76
Research Site
Frankfurt, Germany, 60596
Actively Recruiting
77
Research Site
Halle, Germany, 06108
Actively Recruiting
78
Research Site
Hanover, Germany, 30625
Actively Recruiting
79
Research Site
Konstanz, Germany, 78464
Actively Recruiting
80
Research Site
München, Germany, 80336
Actively Recruiting
81
Research Site
München-Pasing, Germany, 81241
Actively Recruiting
82
Research Site
Athens, Greece, 11527
Actively Recruiting
83
Research Site
Athens, Greece, 12462
Actively Recruiting
84
Research Site
Athens, Greece, 15126
Actively Recruiting
85
Research Site
Athens, Greece, 17562
Actively Recruiting
86
Research Site
Ioannina, Greece, 45500
Actively Recruiting
87
Research Site
Larissa, Greece, 41110
Actively Recruiting
88
Research Site
Pátrai, Greece, 26500
Actively Recruiting
89
Research Site
Thessaloniki, Greece, 57010
Actively Recruiting
90
Research Site
Ashkelon, Israel, 7830604
Actively Recruiting
91
Research Site
Haifa, Israel, 34362
Actively Recruiting
92
Research Site
Jerusalem, Israel, 00000
Actively Recruiting
93
Research Site
Jerusalem, Israel, 91031
Actively Recruiting
94
Research Site
Ramat Gan, Israel, 52621
Actively Recruiting
95
Research Site
Tel Aviv, Israel, 6423906
Actively Recruiting
96
Research Site
Milan, Italy, 20122
Actively Recruiting
97
Research Site
Palermo, Italy, 90127
Actively Recruiting
98
Research Site
Pavia, Italy, 27100
Actively Recruiting
99
Research Site
Perugia, Italy, 06129
Actively Recruiting
100
Research Site
Roma, Italy, 00163
Actively Recruiting
101
Research Site
Rozzano, Italy, 20089
Actively Recruiting
102
Research Site
Torrette, Italy, 60126
Actively Recruiting
103
Research Site
Bunkyō City, Japan, 113-8655
Not Yet Recruiting
104
Research Site
Gifu, Japan, 500-8717
Not Yet Recruiting
105
Research Site
Hiratsuka-shi, Japan, 254-8502
Not Yet Recruiting
106
Research Site
Kamogawa-shi, Japan, 296-0041
Not Yet Recruiting
107
Research Site
Kiyose-shi, Japan, 204-8522
Actively Recruiting
108
Research Site
Kiyose-shi, Japan, 204-8585
Not Yet Recruiting
109
Research Site
Kurashiki-shi, Japan, 710-8602
Not Yet Recruiting
110
Research Site
Miyazaki, Japan, 889-1692
Not Yet Recruiting
111
Research Site
Nagasaki, Japan, 852-8501
Not Yet Recruiting
112
Research Site
Ogi, Japan, 845-0032
Actively Recruiting
113
Research Site
Shinjuku-ku, Japan, 160-8582
Not Yet Recruiting
114
Research Site
Shinjuku-ku, Japan, 162-8655
Not Yet Recruiting
115
Research Site
Urayasu-shi, Japan, 279-0021
Not Yet Recruiting
116
Research Site
Bandar Puncak Alam, Malaysia, 42300
Actively Recruiting
117
Research Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
118
Research Site
Sibu, Malaysia, 96000
Actively Recruiting
119
Research Site
Amsterdam, Netherlands, 1081 HV
Not Yet Recruiting
120
Research Site
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
121
Research Site
Zutphens, Netherlands, 7207 AE
Withdrawn
122
Research Site
Bellavista, Peru, CALLAO 2
Withdrawn
123
Research Site
Callao, Peru, Bellavista
Not Yet Recruiting
124
Research Site
Lima, Peru, 15023
Not Yet Recruiting
125
Research Site
Lima, Peru, 15036
Actively Recruiting
126
Research Site
Lima, Peru, 15038
Actively Recruiting
127
Research Site
Lima, Peru, 15082
Not Yet Recruiting
128
Research Site
Lima, Peru, 15088
Withdrawn
129
Research Site
Lima, Peru, LIMA 1
Actively Recruiting
130
Research Site
Lima, Peru, LIMA 29
Withdrawn
131
Research Site
Iloilo City, Philippines, 5000
Not Yet Recruiting
132
Research Site
Manila, Philippines, 1000
Not Yet Recruiting
133
Research Site
Quezon City, Philippines, 1100
Not Yet Recruiting
134
Research Site
Tondo, Philippines, 1012
Not Yet Recruiting
135
Research Site
Anyang-si, South Korea, 14068
Actively Recruiting
136
Research Site
Cheongju-si, South Korea, 28644
Actively Recruiting
137
Research Site
Daegu, South Korea, 42415
Actively Recruiting
138
Research Site
Seongnam-si, South Korea, 13620
Actively Recruiting
139
Research Site
Seoul, South Korea, 04763
Actively Recruiting
140
Research Site
Seoul, South Korea, 05030
Actively Recruiting
141
Research Site
Seoul, South Korea, 05505
Actively Recruiting
142
Research Site
Seoul, South Korea, 07441
Actively Recruiting
143
Research Site
Ulsan, South Korea, 44033
Actively Recruiting
144
Research Site
Barcelona, Spain, 08003
Actively Recruiting
145
Research Site
Barcelona, Spain, 08036
Actively Recruiting
146
Research Site
Benalmádena, Spain, 29631
Actively Recruiting
147
Research Site
Madrid, Spain, 28040
Actively Recruiting
148
Research Site
Madrid, Spain, 28046
Actively Recruiting
149
Research Site
Mérida, Spain, 06800
Not Yet Recruiting
150
Research Site
Patraix, Spain, 46017
Actively Recruiting
151
Research Site
Valencia, Spain, 46009
Actively Recruiting
152
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
153
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
154
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
155
Research Site
Taipei, Taiwan, 0116
Actively Recruiting
156
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
157
Research Site
Taipei, Taiwan, 110
Actively Recruiting
158
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
159
Research Site
Bang Kra So, Thailand, 11000
Actively Recruiting
160
Research Site
Bangkok, Thailand, 10400
Actively Recruiting
161
Research Site
Muang, Thailand, 40002
Actively Recruiting
162
Research Site
Muang, Thailand, 50200
Actively Recruiting
163
Research Site
Pathum Thani, Thailand, 12120
Actively Recruiting
164
Research Site
Adana, Turkey (Türkiye), 1330
Actively Recruiting
165
Research Site
Ankara, Turkey (Türkiye), 6340
Actively Recruiting
166
Research Site
Diyarbakır, Turkey (Türkiye), 21280
Actively Recruiting
167
Research Site
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
168
Research Site
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
169
Research Site
Mersin, Turkey (Türkiye), 33343
Actively Recruiting
170
Research Site
Zeytinburnu, Turkey (Türkiye), 34020
Actively Recruiting
171
Research Site
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
172
Research Site
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
173
Research Site
Brighton, United Kingdom, BN2 1ES
Actively Recruiting
174
Research Site
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
175
Research Site
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
176
Research Site
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
177
Research Site
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
178
Research Site
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
179
Research Site
Manchester, United Kingdom, M23 9LT
Actively Recruiting
180
Research Site
Can Tho, Vietnam, 900000
Not Yet Recruiting
181
Research Site
Haiphong, Vietnam, 180000
Not Yet Recruiting
182
Research Site
Hanoi, Vietnam, 100000
Not Yet Recruiting
183
Research Site
Hà Nội, Vietnam, 100000
Not Yet Recruiting
184
Research Site
Ho Chi Minh City, Vietnam, 700000
Not Yet Recruiting
185
Research Site
Huế, Vietnam, 530000
Not Yet Recruiting
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Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Frequently Asked Questions
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Published Research Related To This Trial
Development and initial validation of the bronchiectasis exacerbation and symptom tool (BEST).
Amaia Artaraz, Megan L Crichton, Simon Finch...
https://pubmed.ncbi.nlm.nih.gov/31931782Characterization of bronchiectasis in the elderly.
Giuseppe Bellelli, James D Chalmers, Giovanni Sotgiu...
https://pubmed.ncbi.nlm.nih.gov/27692133The bronchiectasis severity index. An international derivation and validation study.
James D Chalmers, Pieter Goeminne, Stefano Aliberti...
https://pubmed.ncbi.nlm.nih.gov/24328736Management of bronchiectasis in adults.
James D Chalmers, Stefano Aliberti, Francesco Blasi
https://pubmed.ncbi.nlm.nih.gov/25792635Bronchiectasis.
James D Chalmers, Anne B Chang, Sanjay H Chotirmall...
https://pubmed.ncbi.nlm.nih.gov/30442957Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis.
James D Chalmers, Stefano Aliberti, Anna Filonenko...
https://pubmed.ncbi.nlm.nih.gov/29357265Bronchiectasis: new therapies and new perspectives.
James D Chalmers, Sanjay H Chotirmall
https://pubmed.ncbi.nlm.nih.gov/29478908Influence of pseudomonas aeruginosa on exacerbation in patients with bronchiectasis.
Kiran Chawla, Shashidhar Vishwanath, Mohan K Manu...
https://pubmed.ncbi.nlm.nih.gov/25722615Pseudomonas aeruginosa associated with severity of non-cystic fibrosis bronchiectasis measured by the modified bronchiectasis severity score (BSI) and the FACED: The US bronchiectasis and NTM Research Registry (BRR) study.
Radmila Choate, Timothy R Aksamit, David Mannino...
https://pubmed.ncbi.nlm.nih.gov/33401148