Trial Outcomes & Findings for Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01462929)

Last Updated: 2017-01-04

Results Overview

Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

414 participants

Primary outcome timeframe

Week 6

Results posted on

2017-01-04

Participant Flow

This study was conducted in 49 sites investigators in 4 countries (3 sites in the Czech Republic, 23 in Germany, 8 in Hungary and 15 in Poland). 8 sites (3 in Germany, 3 in Hungary and 2 in Poland) did not randomise any patients. The first patient was screened in Oct 2011 and the last patient visit was in Mar 2012.

Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.

Participant milestones

Participant milestones
Measure	Aclidinium Bromide 400 µg BID Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Overall Study STARTED	171	158	85
Overall Study COMPLETED	166	154	80
Overall Study NOT COMPLETED	5	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Aclidinium Bromide 400 µg BID Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Overall Study Adverse Event	3	3	4
Overall Study Withdrawal by Subject	2	1	0
Overall Study Lack of Efficacy	0	0	1

Baseline Characteristics

Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aclidinium Bromide 400 µg BID n=171 Participants Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily n=158 Participants Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo n=85 Participants Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).	Total n=414 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 8.2 • n=5 Participants	62.8 years STANDARD_DEVIATION 7.9 • n=7 Participants	62.2 years STANDARD_DEVIATION 8.2 • n=5 Participants	62.3 years STANDARD_DEVIATION 8.1 • n=4 Participants
Gender Female	57 Participants n=5 Participants	42 Participants n=7 Participants	37 Participants n=5 Participants	136 Participants n=4 Participants
Gender Male	114 Participants n=5 Participants	116 Participants n=7 Participants	48 Participants n=5 Participants	278 Participants n=4 Participants
Region of Enrollment Hungary	18 participants n=5 Participants	16 participants n=7 Participants	10 participants n=5 Participants	44 participants n=4 Participants
Region of Enrollment Czech Republic	5 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment Poland	64 participants n=5 Participants	58 participants n=7 Participants	32 participants n=5 Participants	154 participants n=4 Participants
Region of Enrollment Germany	84 participants n=5 Participants	81 participants n=7 Participants	40 participants n=5 Participants	205 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 6

Population: Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value

Outcome measures

Outcome measures
Measure	Aclidinium Bromide 400 µg BID n=170 Participants Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily n=158 Participants Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo n=85 Participants Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment	0.065 Liters Standard Error 0.017	0.055 Liters Standard Error 0.018	-0.085 Liters Standard Error 0.023

SECONDARY outcome

Timeframe: Week 6

Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Outcome measures

Outcome measures
Measure	Aclidinium Bromide 400 µg BID n=170 Participants Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily n=158 Participants Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo n=85 Participants Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment	0.032 Liters Standard Error 0.017	-0.006 Liters Standard Error 0.018	-0.128 Liters Standard Error 0.024

Adverse Events

Aclidinium Bromide 400 µg BID

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Tiotropium 18 μg Once-daily

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aclidinium Bromide 400 µg BID n=171 participants at risk Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily n=158 participants at risk Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo n=85 participants at risk Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Psychiatric disorders Mental Disorder	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Cardiac disorders Angina Unstable	0.00% 0/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.63% 1/158 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.63% 1/158 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Gastrointestinal disorders Dysphagia	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.63% 1/158 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Infections and infestations Pneumonia	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Infections and infestations Viral Infection	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Nervous system disorders Transient Ischaemic Attack	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.58% 1/171 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.63% 1/158 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Vascular disorders Peripheral Vascular Disorder	0.00% 0/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.63% 1/158 • Number of events 1 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	0.00% 0/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.

Other adverse events

Other adverse events
Measure	Aclidinium Bromide 400 µg BID n=171 participants at risk Aclidinium bromide 400 µg administered twice per day Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) AND 1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler.	Tiotropium 18 μg Once-daily n=158 participants at risk Tiotropium 18 μg administered once daily Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler. Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) AND 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler.	Placebo n=85 participants at risk Placebo Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h).
Infections and infestations Nasopharyngitis	6.4% 11/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	5.1% 8/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	2.4% 2/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.
Nervous system disorders Headache	3.5% 6/171 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	7.0% 11/158 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.	4.7% 4/85 • 8 Weeks A follow-up was performed by means of a visit or a phone contact, as considered appropriate, 2 weeks (±3 days) after the last Investigational Medicinal Product dose administration in order to assess new or ongoing AEs, abnormal values of study variables (laboratory evaluations, BP or ECG) or COPD exacerbation.

Additional Information

AstraZeneca Clinical

Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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