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Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients (ACTIVATE)

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ClinicalTrials.gov Identifier: NCT02424344
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Aclidinium/Formoterol
Drug: Placebo
Enrollment 267
Recruitment Details This study was conducted at 26 study centers, 15 in Germany, 4 in Hungary, 3 in Spain and 4 in Canada. The first patient was enrolled in April 2015 and the last patient visit was in July 2016.
Pre-assignment Details 335 patients were screened; 267 were assessed as eligible and were randomized into the study. 68 patients failed screening. The main reason for screening failure was non-fulfilment of inclusion or exclusion criteria (16.7%).
Arm/Group Title AB/FF 400/12 μg Placebo
Hide Arm/Group Description Aclidinium Bromide/Formoterol Fumarate 400/12 μg Placebo to Aclidinium/Formoterol
Period Title: Overall Study
Started 134 133
Completed 127 123
Not Completed 7 10
Reason Not Completed
Lack of Efficacy             0             1
Withdrawal by Subject             2             1
Lost to Follow-up             1             0
Adverse Event             4             8
Arm/Group Title AB/FF 400/12 μg Placebo Total
Hide Arm/Group Description Aclidinium Bromide/Formoterol Fumarate 400/12 μg Placebo to Aclidinium/Formoterol Total of all reporting groups
Overall Number of Baseline Participants 134 133 267
Hide Baseline Analysis Population Description
The Safety Population defined as all randomized patients who took at least one dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 133 participants 267 participants
62.6  (7.9) 62.1  (7.7) 62.3  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 133 participants 267 participants
Female
53
  39.6%
54
  40.6%
107
  40.1%
Male
81
  60.4%
79
  59.4%
160
  59.9%
1.Primary Outcome
Title Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment
Hide Description Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of investigational product (IP) - who had available trough FRC values at baseline and Week 4.
Arm/Group Title AB/FF 400/12 μg Placebo
Hide Arm/Group Description:
Aclidinium Bromide/Formoterol Fumarate 400/12 μg
Placebo to Aclidinium/Formoterol
Overall Number of Participants Analyzed 124 125
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.162  (0.050) -0.037  (0.050)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AB/FF 400/12 μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method ANCOVA
Comments Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors
Method of Estimation Estimation Parameter Least Square mean difference
Estimated Value -0.125
Confidence Interval (2-Sided) 95%
-0.259 to 0.010
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8
Hide Description

The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation.

Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.

Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population - which was equal to the safety population, defined as all participants who took at least one dose of investigational product - who had available ET values at baseline and Week 8.
Arm/Group Title AB/FF 400/12 μg Placebo
Hide Arm/Group Description:
Aclidinium Bromide/Formoterol Fumarate 400/12 μg
Placebo to Aclidinium/Formoterol
Overall Number of Participants Analyzed 124 121
Least Squares Mean (Standard Error)
Unit of Measure: Seconds
50.7  (18.1) -4.6  (18.2)
3.Secondary Outcome
Title Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8
Hide Description

Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire.

Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.

Baseline was defined as mean of steps/day assessed during the week before the randomisation visit.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of IP

- who had available activity data (compliant criterion).

Arm/Group Title AB/FF 400/12 μg Placebo
Hide Arm/Group Description:
Aclidinium Bromide/Formoterol Fumarate 400/12 μg
Placebo to Aclidinium/Formoterol
Overall Number of Participants Analyzed 118 117
Measure Type: Number
Unit of Measure: Percent of inactive participants
41.53 50.43
Time Frame From Screening, Week -2 (Days -17 to -11) to Follow-up, Week 10 (Day 70+3)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AB/FF 400/12 μg Placebo
Hide Arm/Group Description Aclidinium Bromide/Formoterol Fumarate 400/12 μg Placebo to Aclidinium/Formoterol
All-Cause Mortality
AB/FF 400/12 μg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
AB/FF 400/12 μg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/134 (1.49%)      3/133 (2.26%)    
Eye disorders     
Lens dislocation  1  0/134 (0.00%)  0 1/133 (0.75%)  1
General disorders     
Fatigue  1  1/134 (0.75%)  1 0/133 (0.00%)  0
Infections and infestations     
Diverticulitis  1  0/134 (0.00%)  0 1/133 (0.75%)  1
Injury, poisoning and procedural complications     
Pubis fracture  1  1/134 (0.75%)  1 0/133 (0.00%)  0
Meniscus injury  1  0/134 (0.00%)  0 1/133 (0.75%)  1
Nervous system disorders     
Ataxia  1  1/134 (0.75%)  1 0/133 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AB/FF 400/12 μg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/134 (10.45%)      24/133 (18.05%)    
Infections and infestations     
Nasopharyngitis  1  14/134 (10.45%)  14 13/133 (9.77%)  13
Nervous system disorders     
Headache  1  4/134 (2.99%)  4 12/133 (9.02%)  24
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 18.0
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.
Publication of the results by the Principal Investigator (PI) will be subject to mutual agreement between the PI and the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02424344    
Other Study ID Numbers: D6570C00001
M-40464-33 ( Other Identifier: Clinical Trial Protocol Code )
2014-005318-50 ( EudraCT Number )
First Submitted: April 20, 2015
First Posted: April 23, 2015
Results First Submitted: July 14, 2017
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018