Trial Outcomes & Findings for Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00706914)

NCT ID: NCT00706914

Last Updated: 2017-05-15

Results Overview

Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

156 participants

Primary outcome timeframe

Week 4 of treatment

Results posted on

2017-05-15

Participant Flow

This study was conducted in 31 sites in the United States (US). All sites screened at least one patient and, of these 31 sites, three sites did not enroll any patients. The first patient was screened in March 2008 and the last patient visit was in February 2009.

Participant milestones

Participant milestones
Measure	Once-daily Aclidinium/Formoterol Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID Formoterol fumarate 12 μg twice-daily (BID)
Overall Study STARTED	63	62	31
Overall Study COMPLETED	57	58	30
Overall Study NOT COMPLETED	6	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Once-daily Aclidinium/Formoterol Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID Formoterol fumarate 12 μg twice-daily (BID)
Overall Study Lack of Efficacy	0	1	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Adverse Event	2	2	0
Overall Study Protocol Violation	3	1	1

Baseline Characteristics

Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Once-daily Aclidinium/Formoterol n=63 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=62 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)	Total n=156 Participants Total of all reporting groups
Age, Continuous	63.0 Years STANDARD_DEVIATION 7.2 • n=5 Participants	63.9 Years STANDARD_DEVIATION 9.0 • n=7 Participants	62.2 Years STANDARD_DEVIATION 10.1 • n=5 Participants	63.2 Years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	15 Participants n=5 Participants	68 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	37 Participants n=7 Participants	16 Participants n=5 Participants	88 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 4 of treatment

Population: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all

Outcome measures

Outcome measures
Measure	Once-daily Aclidinium/Formoterol n=62 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=61 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)
Change From Baseline in Weekly Average Nocturnal Symptom Scores	-0.15 Units on a scale Interval -0.33 to 0.04	-0.09 Units on a scale Interval -0.26 to 0.08	-0.35 Units on a scale Interval -0.59 to -0.12

PRIMARY outcome

Timeframe: Week 4 of treatment

Population: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon

Outcome measures

Outcome measures
Measure	Once-daily Aclidinium/Formoterol n=62 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=61 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores	-0.17 Units on a scale Interval -0.34 to -0.01	0.13 Units on a scale Interval -0.07 to 0.32	-0.00 Units on a scale Interval -0.2 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 of treatment

Population: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day

Outcome measures

Outcome measures
Measure	Once-daily Aclidinium/Formoterol n=57 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=57 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)	0.097 Liters Interval 0.059 to 0.135	0.084 Liters Interval 0.04 to 0.128	0.118 Liters Interval 0.07 to 0.166

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 of treatment

Population: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

Outcome measures

Outcome measures
Measure	Once-daily Aclidinium/Formoterol n=62 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=61 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)	0.355 Liters Interval 0.308 to 0.403	0.319 Liters Interval 0.265 to 0.373	0.280 Liters Interval 0.22 to 0.341

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 of treatment

Population: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose

Outcome measures

Outcome measures
Measure	Once-daily Aclidinium/Formoterol n=62 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=61 Participants Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 Participants Formoterol fumarate 12 μg twice-daily (BID)
Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)	0.257 Liters Interval 0.211 to 0.302	0.226 Liters Interval 0.176 to 0.276	0.200 Liters Interval 0.142 to 0.258

Adverse Events

Once-daily Aclidinium/Formoterol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Morning Aclidinium/Formoterol Plus Evening Formoterol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Formoterol BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Once-daily Aclidinium/Formoterol n=63 participants at risk Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=62 participants at risk Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 participants at risk Formoterol fumarate 12 μg twice-daily (BID)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/63 • 29 ± 2 days	1.6% 1/62 • 29 ± 2 days	0.00% 0/31 • 29 ± 2 days
Nervous system disorders Drug withdrawal convulsions	1.6% 1/63 • 29 ± 2 days	0.00% 0/62 • 29 ± 2 days	0.00% 0/31 • 29 ± 2 days

Other adverse events

Other adverse events
Measure	Once-daily Aclidinium/Formoterol n=63 participants at risk Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening	Morning Aclidinium/Formoterol Plus Evening Formoterol n=62 participants at risk Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening	Formoterol BID n=31 participants at risk Formoterol fumarate 12 μg twice-daily (BID)
Gastrointestinal disorders Nausea	0.00% 0/63 • 29 ± 2 days	0.00% 0/62 • 29 ± 2 days	6.5% 2/31 • 29 ± 2 days

Additional Information

Esther Garcia

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and sponsor.
Publication restrictions are in place

Restriction type: OTHER