Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	COPD
Interventions:	Drug: Aclidinium bromide 400 μg bid Drug: Tiotropium 18 μg once-daily Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 2 sites in Germany. The first patient was screened in Mar 2009 and the last patient visit was in Jul 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients had at least a 5-day run-in period (and a maximum of 9 days) to assess patient’s clinical stability.

Reporting Groups

	Description
Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID	The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days.

Participant Flow for 3 periods

Period 1: Treatment Period 1

	Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg	Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo	Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo	Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID	Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg	Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	4	5
NOT COMPLETED	0	0	0	0	1	0
Adverse Event	0	0	0	0	1	0

Period 2: Treatment Period 2

	Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg	Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo	Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo	Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID	Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg	Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID
STARTED	5	5	5	5	4	5
COMPLETED	4	5	5	5	4	5
NOT COMPLETED	1	0	0	0	0	0
Adverse Event	1	0	0	0	0	0

Period 3: Treatment Period 3

	Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg	Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo	Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo	Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID	Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg	Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID
STARTED	4	5	5	5	4	5
COMPLETED	4	5	4	5	4	5
NOT COMPLETED	0	0	1	0	0	0
Adverse Event	0	0	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall Study Population	All patients randomized into the crossover study

Baseline Measures

	Overall Study Population
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	22
>=65 years	8
Age [units: years] Mean ± Standard Deviation	58.4 ± 7.9
Gender [units: participants]
Female	11
Male	19
Region of Enrollment [units: participants]
Germany	30

Outcome Measures

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1. Primary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. [ Time Frame: Day 15 ]

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2. Secondary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment [ Time Frame: Day 15 ]

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3. Secondary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ]

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4. Secondary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment [ Time Frame: Day 15 ]

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8. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ]

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9. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ]

Show Outcome Measure 12

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: All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.

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
No text entered.

Results Point of Contact:

Name/Title: Clinical Project Leader and Trial Manager
Organization: Almirall S.A.
phone: +34 93 291 3200

No publications provided by Almirall, S.A.

Publications automatically indexed to this study:

Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falqués M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 μg twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-52. Epub 2011 Sep 8.

Responsible Party:	Almirall, S.A.
ClinicalTrials.gov Identifier:	NCT00868231 History of Changes
Other Study ID Numbers:	M/34273/23
Study First Received:	March 23, 2009
Results First Received:	August 14, 2012
Last Updated:	August 14, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices