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Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD9164 100 mcg First, then Placebo for Spririva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation |
|
| AZD9164 400 mcg First, then Placebo for Spiriva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation |
|
| AZD9164 1200 mcg First, then Placebo for Spiriva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation |
|
| Spiriva 18 mcg First, then Placebo for AZD9164 | Active Comparator | 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) |
|
| Placebo for Spiriva First, then Placebo for AZD9164 | Placebo Comparator | 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9164 | Drug | Solution for inhalation through nebulization, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | 22 h, 24 h, 26 h |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose | Average FEV1 value | 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
| Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif Bjermer, Prof, MD, PhD | University Hospital in Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23098686 | Derived | Bjermer L, Bengtsson T, Jorup C, Lotvall J. Local and systemic effects of inhaled AZD9164 compared with tiotropium in patients with COPD. Respir Med. 2013 Jan;107(1):84-90. doi: 10.1016/j.rmed.2012.09.014. Epub 2012 Oct 23. |
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The study has been performed at four centers in Sweden. The first subject entered the study on 23 June 2009 and the last subject completed the study on 6 November 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AZD9164 100 Mcg First, Then Placebo |
| |||||||||||||
| AZD9164 400 Mcg First, Then Placebo |
| |||||||||||||
| AZD9164 1200 Mcg First, Then Placebo |
| |||||||||||||
| Spiriva 18 Mcg First, Then Placebo |
| |||||||||||||
| Placebo |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Number of Baseline Participants |
| 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 | Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | Posted | Mean | Standard Deviation | L | 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
|
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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 | AZD9164 100 Mcg First, Then Placebo for Spiriva | 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +441509645895 | clinicaltrialtransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C570585 | AZD9164 |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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|
| Tiotropium | Drug | Dry powder for inhalation, single dose |
|
|
| Placebo | Drug | Placebo |
|
15 min FEV1 value |
| 15 min |
| Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | 0, 30 min, 2 h, 4 h |
| Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | 0, 30 min, 2 h, 4 h |
| Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | 0, 30 min, 2 h, 4 h |
| Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | 0, 30 min, 2 h, 4 h |
| QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value | 0, 30 min, 2 h, 4 h |
| Plasma AZD9164 Cmax | Maximum plasma concentration of AZD9164 | 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
| Plasma AZD9164 AUC0-24 | Area under the AZD9164 plasma concentration curve | 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
| Luleå |
| Sweden |
| Research Site | Lund | Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| AZD9164 1200 Mcg First, Then Placebo for Spiriva |
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation |
| OG003 | Spiriva 18 Mcg First, Then Placebo for AZD9164 | 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) |
| OG004 | Placebo for Spiriva First, Then Placebo for AZD9164 | 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) |
|
|
| Primary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | Posted | Mean | Standard Deviation | L | 22 h, 24 h, 26 h |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose | Average FEV1 value | Posted | Mean | Standard Deviation | L | 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose | 15 min FEV1 value | Posted | Mean | Standard Deviation | L | 15 min |
|
|
|
| Secondary | Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | Posted | Mean | Standard Deviation | mmHg | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | Posted | Mean | Standard Deviation | mmHg | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | Posted | Mean | Standard Deviation | bpm | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | Posted | Mean | Standard Deviation | bpm | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value | Posted | Mean | Standard Deviation | ms | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Plasma AZD9164 Cmax | Maximum plasma concentration of AZD9164 | Posted | Geometric Mean | Full Range | nmol/L | 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
|
|
|
| Secondary | Plasma AZD9164 AUC0-24 | Area under the AZD9164 plasma concentration curve | Posted | Geometric Mean | Full Range | nmol*h/L | 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
|
|
|
| 0 |
| 28 |
| 4 |
| 28 |
| EG001 | AZD9164 400 Mcg First, Then Placebo for Spiriva | 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation | 0 | 28 | 15 | 28 |
| EG002 | AZD9164 1200 Mcg First, Then Placebo for Spiriva | 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation | 0 | 28 | 27 | 28 |
| EG003 | Spiriva 18 Mcg First, Then Placebo for AZD9164 | 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) | 0 | 28 | 2 | 28 |
| EG004 | Placebo for Spiriva First, Then Placebo for AZD9164 | 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) | 0 | 28 | 3 | 28 |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |