Trial Outcomes & Findings for BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH (NCT NCT02375724)
NCT ID: NCT02375724
Last Updated: 2017-04-21
Results Overview
The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms
COMPLETED
PHASE4
300 participants
Baseline to Week 8
2017-04-21
Participant Flow
Patients were randomized in 30 study sites in 5 countries Germany (10 sites), Hungary (6), Italy (2), Spain (9) and the United Kingdom (3) First patient was enrolled in March 2015 and last patient last visit was in November 2015
300 patients were screened; 269 were assessed as eligible and were randomized into the study Thirty-one patients failed screening, with the main reason for screening failure being non-fulfilment of the inclusion or exclusion criteria (24 patients)
Participant milestones
| Measure |
Aclidinium 400 μg
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
134
|
|
Overall Study
COMPLETED
|
129
|
128
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Aclidinium 400 μg
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
4
|
Baseline Characteristics
BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
Baseline characteristics by cohort
| Measure |
Aclidinium 400 μg
n=135 Participants
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=134 Participants
Placebo BID administered by Genuair® multidose dry powder inhaler
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
62.0 Years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
62.0 Years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo
The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms
Outcome measures
| Measure |
Aclidinium 400 μg
n=131 Participants
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=133 Participants
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period
|
-1.75 Score
Standard Error 0.342
|
-0.73 Score
Standard Error 0.342
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo
The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms
Outcome measures
| Measure |
Aclidinium 400 μg
n=131 Participants
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=133 Participants
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period
|
-0.54 Score
Standard Error 0.090
|
-0.33 Score
Standard Error 0.090
|
SECONDARY outcome
Timeframe: Week 8Population: Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product LCQ data were available for 126/135 patients receiving aclidinium and 128/134 receiving placebo
The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life
Outcome measures
| Measure |
Aclidinium 400 μg
n=126 Participants
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=128 Participants
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8
|
1.18 Score
Standard Error 0.214
|
1.24 Score
Standard Error 0.214
|
Adverse Events
Aclidinium 400 μg
Placebo
Serious adverse events
| Measure |
Aclidinium 400 μg
n=135 participants at risk
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=134 participants at risk
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.74%
1/135 • Day 70±3
|
0.00%
0/134 • Day 70±3
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/135 • Day 70±3
|
0.75%
1/134 • Day 70±3
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.74%
1/135 • Day 70±3
|
0.00%
0/134 • Day 70±3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/135 • Day 70±3
|
0.75%
1/134 • Day 70±3
|
Other adverse events
| Measure |
Aclidinium 400 μg
n=135 participants at risk
Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
|
Placebo
n=134 participants at risk
Placebo BID administered by Genuair® multidose dry powder inhaler
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.2%
7/135 • Day 70±3
|
9.7%
13/134 • Day 70±3
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
4/135 • Day 70±3
|
6.7%
9/134 • Day 70±3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication and/or presentation whether complete or partial, of any part of the data or results of this trial will not be allowed until global publication and study results disclosure by the sponsor as per EMA / FDA regulatory compliance obligations, and only after mutual agreement between the investigator and the sponsor
- Publication restrictions are in place
Restriction type: OTHER