Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00629239

First received: February 25, 2008

Last updated: November 4, 2010

Last verified: November 2010

History of Changes

Results First Received: November 4, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease (COPD)
Interventions:	Drug: AZD4818 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One participant was excluded in the analysis sets since this participat is non-informative both in terms of efficacy and safety, and was immediately withdrawn for non-treatment related reasons. AZD4818 Turbuhaler group will include 33 patients in all other sections

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AZD4818	AZD4818 Turbuhaler
Placebo	Placebo

Participant Flow: Overall Study

	AZD4818	Placebo
STARTED	34	32
COMPLETED	26	28
NOT COMPLETED	8	4
Adverse Event	7	4
Physician Decision	1	0

Baseline Characteristics

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Reporting Groups

	Description
AZD4818	AZD4818 Turbuhaler
Placebo	Placebo
Total	Total of all reporting groups

Baseline Measures

	AZD4818	Placebo	Total
Number of Participants [units: participants]	33	32	65
Age [units: years] Mean ( Full Range )	65 ( 51 to 78 )	66 ( 42 to 77 )	65 ( 42 to 78 )
Gender [units: Participants]
Female	10	8	18
Male	23	24	47

Outcome Measures

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1. Primary:

Number of Patients Experiencing Adverse Events [ Time Frame: At all study visits ]

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2. Secondary:

Forced Expiratory Volume 1 (FEV1) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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3. Secondary:

Forced Vital Capacity (FVC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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4. Secondary:

Vital Capacity (VC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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5. Secondary:

Inspiratory Capacity (IC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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6. Secondary:

Forced Expiratory Flow (FEF) 25%-75% [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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7. Secondary:

Peak Expiratory Flow (PEF) Morning [ Time Frame: Daily during run-in and treatment ]

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8. Secondary:

Peak Expiratory Flow (PEF) Evening [ Time Frame: Daily during run-in and treatment ]

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9. Secondary:

The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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10. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness [ Time Frame: Daily during run-in and treatment ]

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11. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness [ Time Frame: Daily during run-in and treatment ]

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12. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score [ Time Frame: Daily during run-in and treatment ]

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13. Secondary:

Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score [ Time Frame: Daily during run-in and treatment ]

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14. Secondary:

6-minute Walk Test [ Time Frame: Before treatment and after 4 weeks of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PI agrees to collaborate with AZ in regard to the contents and formation of any publication or disclosure and to considerate the comments,views and opinions offered by AZ. Prior to any publication or disclosure the PI will provide AZ with preliminary data and drafts of proposed publication or disclosure and the proposed final manuscript. AZ will have a period of 30 days from receipt of the proposed final manuscript to review and may require submission for publication or disclosure be delayed

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Bengt Larsson/MD PhD Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00629239 History of Changes
Other Study ID Numbers:	D3540C00005
Study First Received:	February 25, 2008
Results First Received:	November 4, 2010
Last Updated:	November 4, 2010
Health Authority:	Sweden: Medical Products Agency Norway: Norwegian Medicines Agency Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Netherlands: Medicines Evaluation Board (MEB)

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