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The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD5423 75ug |
|
| 2 | Experimental | AZD5423 300ug |
|
| 3 | Active Comparator | Budesonide 200 microgram |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | Suspension for nebulisation once daily 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1 | LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1 | From Randomization to end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge | Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1 | From Randomization to end of treatment |
| Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christer Hultquist | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Calgary | Alberta | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25473939 | Derived | Gauvreau GM, Boulet LP, Leigh R, Cockcroft DW, Killian KJ, Davis BE, Deschesnes F, Watson RM, Swystun V, Mardh CK, Wessman P, Jorup C, Aurivillius M, O'Byrne PM. A nonsteroidal glucocorticoid receptor agonist inhibits allergen-induced late asthmatic responses. Am J Respir Crit Care Med. 2015 Jan 15;191(2):161-7. doi: 10.1164/rccm.201404-0623OC. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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Total 27 patients enrolled, 20 (74.1%) patients were randomised to receive a treatment sequence consisting of 4 different treatment in random order. From 20 randomised patients, 18 (90%) patients completed the study and 2 (10%) patients were withdrawn from the study due to consumption of disallowed medication
Patients were enrolled from 4 centres in the AllerGen CIC group in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACBP | AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo |
| FG001 | APBC | AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid |
| FG002 | BACP | AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo |
| FG003 | BPCA | AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg |
| FG004 | CAPB | Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od |
| FG005 | CBAP | Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo |
| FG006 | CBPA | Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg |
| FG007 | PBAC | Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid |
| FG008 | PCAB | Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od |
| FG009 | PCBA | Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Treatment Period |
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| Period 2 - Washout |
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| Period 3 - Second Treatment Period |
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| Period 4 - Washout |
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| Period 5 - Third Treatment Period |
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| Period 6 - Washout |
| |||||||||||||
| Period 7 - Fourth Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Total | Total number of patients randomised and treated in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1 | LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1 | PD Analysis set | Posted | Geometric Mean | Full Range | Percentage | From Randomization to end of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - 75ug AZD5423 | 75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONJUNCTIVITIS | Eye disorders | Systematic Assessment |
Of the 27 patients enrolled, 20 (74.1%) patient were randomised to receive a treatment sequence consisting of 4 different treatment in random order. 19 patients completed each individual treatment period and 17 patients completed all 4 treatment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C587250 | 2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide 200 microgram |
| Drug |
Dry powder for inhalation twice daily 7 days |
|
|
| Placebo | Drug | Solution for nebulisation once daily 7 days |
|
| Placebo | Drug | Solution for nebulisation once daily 7 days |
|
AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1 |
| From Randomization to end of treatment |
| Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | Day 1 (pre-dose) |
| Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | Day 5 ([post-dose] pre allergen challenge) |
| Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | Day 7 ([post-dose] 24 hours post allergen challenge) |
| Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | Day 5 (post dose) |
| Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | Day 6 ([post dose] 7 hours post allergen challenge) |
| Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | Day 7 ([post dose] 24 hours post allergen challenge) |
| Hamilton |
| Ontario |
| Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Saskatoon | Saskatchewan | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
| OG002 | Arm 3 - 2x200ug Budesonide | 200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence. |
| OG003 | Arm 4 - Placebo | Placebo administered in any of the first, second, third or fourth period of a particular sequence. |
|
|
| Secondary | Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge | Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1 | PD Analysis set | Posted | Geometric Mean | Full Range | Percentage | From Randomization to end of treatment |
|
|
|
| Secondary | Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge | AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1 | PD Analysis set | Posted | Geometric Mean | Full Range | Percentage | From Randomization to end of treatment |
|
|
|
| Secondary | Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | PD Analysis set | Posted | Geometric Mean | Full Range | mg/mL | Day 1 (pre-dose) |
|
|
|
| Secondary | Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | Posted | Geometric Mean | Full Range | mg/mL | Day 5 ([post-dose] pre allergen challenge) |
|
|
|
| Secondary | Airway Hyperresponsiveness by Assessment of Methacholine PC20 | The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC) | Posted | Geometric Mean | Full Range | mg/mL | Day 7 ([post-dose] 24 hours post allergen challenge) |
|
|
|
| Secondary | Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | PD Analysis set | Posted | Mean | Standard Deviation | Percentage | Day 5 (post dose) |
|
|
|
| Secondary | Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | Posted | Mean | Standard Deviation | Percentage | Day 6 ([post dose] 7 hours post allergen challenge) |
|
|
|
| Secondary | Changes in Sputum Eosinophils Differentials (Percentage) | The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge) | Posted | Mean | Standard Deviation | Percentage | Day 7 ([post dose] 24 hours post allergen challenge) |
|
|
|
| 0 |
| 19 |
| 8 |
| 19 |
| EG001 | Arm 2 - 300ug AZD5423 | 300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence. | 0 | 19 | 1 | 19 |
| EG002 | Arm 3 - 2x200ug Budesonide | 2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence. | 0 | 19 | 9 | 19 |
| EG003 | Arm 4 - Placebo | Placebo administered in any of the first, second, third or fourth period of a particular sequence. | 0 | 20 | 9 | 20 |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Systematic Assessment |
|
| PYREXIA | General disorders | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
|
| PHARYNGITIS BACTERIAL | Infections and infestations | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| VIRAL PHARYNGITIS | Infections and infestations | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| SCRATCH | Injury, poisoning and procedural complications | Systematic Assessment |
|
| HELICOBACTER TEST POSITIVE | Investigations | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | Systematic Assessment |
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| DYSMENORRHOEA | Reproductive system and breast disorders | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
PI shall not publish any results until (i) the date of the first Study results publication, or in case of a Multi-Centre Study the first Multi-Centre Results publication, agreed by the participating sites, and (ii) the end of the eighteen (18) month period following the completion or early termination of the Study at all participating sites.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| AUC over 3-7 (Average LAR) |
|