A Trial Assessing LAS34273 in Moderate to Severe Stable C... | NCT00363896

ID	Type	Description	Link
ACCLAIM I	Other Identifier	Almirall,S.A.
CT000740	Other Identifier	Almirall,S.A.

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aclidinium 200 μg once-daily	Experimental	Aclidinium bromide 200 μg once-daily by inhalation	Drug: Aclidinium bromide
Placebo	Placebo Comparator	Placebo once-daily via inhalation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aclidinium bromide	Drug	Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks	Aclidinium 200 μg once-daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough FEV1 (L) at 28 Weeks on Treatment	Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks	Week 28
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment	Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment	Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.	Week 52

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Esther Garcia, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Almirall Investigational Sites#947		Les Escaldes			Andorra
Almirall Investigational Sites#645

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21518460	Derived	Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.

Label	URL
Sponsor web site	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
FG001	Placebo	Placebo by inhalation

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
BG001	Placebo	Placebo by inhalation
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.6± 8.2 BG00161.9± 8.3 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000139 BG00141 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Andorra

Title	Measurements
	BG0003 BG0011 BG002

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

Trough FEV1 (L) at 28 Weeks on Treatment

Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.

Posted

Least Squares Mean

Standard Error

Liters

Week 28

ID	Title	Description
OG000	Aclidinium 200 μg Once-daily	Aclidinium bromide 200 μg once-daily via inhalation
OG001	Placebo	Placebo once-daily via inhalation

Units	Counts
Participants	OG000616 OG001210

Title

Denominators

Categories

Title	Measurements
	OG0001.422± 0.011 OG0011.356± 0.017

Secondary

Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment

Time to first moderate or severe exacerbation:

Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

Posted

Median

95% Confidence Interval

Days

Week 52

ID	Title	Description
OG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily via inhalation
OG001	Placebo	Placebo once-daily via inhalation

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment

Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score

Posted

Number

Percentage of Patients

52 weeks

ID	Title	Description
OG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation
OG001	Placebo	Placebo by inhalation

Units	Counts
Participants	OG000

Primary

Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment

Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks

Posted

Least Squares Mean

Standard Error

Liters

Week 12

ID	Title	Description
OG000	Aclidinium 200 μg Once-daily	Aclidinium bromide 200 μg once-daily via inhalation
OG001	Placebo	Placebo once-daily via inhalation

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aclidinium Bromide 200 μg Once-daily	Aclidinium bromide 200 μg once-daily by inhalation			50	627	232	627
EG001	Placebo	Placebo by inhalation			22	216	76	216

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Angina unstable	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected627 at risk EG0010 events0 affected216 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0011 events1 affected216 at risk
Atrioventricular block	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cardiac arrest	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Extrasystoles	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Mitrial valve incompetence	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Angle closure glaucoma	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cataract cortical	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Open angle glaucoma	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Retinal detachment	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0011 events1 affected216 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Chest pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Sudden cardiac death	General disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected627 at risk EG0010 events0 affected216 at risk
Bronchopneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Hepatitis C	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Lobar pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0011 events1 affected216 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0009 events8 affected627 at risk EG0013 events3 affected216 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Septic shock	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0012 events2 affected216 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Sciatica	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0011 events1 affected216 at risk
Depression suicidal	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Phimosis	Pregnancy, puerperium and perinatal conditions	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected627 at risk EG0012 events2 affected216 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 events2 affected627 at risk EG0010 events0 affected216 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected627 at risk EG0010 events0 affected216 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0011 events1 affected216 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected627 at risk EG0013 events3 affected216 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Cardiovascular insufficiency	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Hypertensive crisis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Iliac artery emolism	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected627 at risk EG0010 events0 affected216 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG000102 affected627 at risk EG00131 affected216 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG00071 affected627 at risk EG00127 affected216 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG00030 affected627 at risk EG00110 affected216 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG00029 affected627 at risk EG0018 affected216 at risk

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms