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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

Tracking Information
First Submitted Date  ICMJE April 20, 2015
First Posted Date  ICMJE April 23, 2015
Results First Submitted Date  ICMJE July 14, 2017
Results First Posted Date  ICMJE October 9, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE April 27, 2015
Actual Primary Completion Date July 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment [ Time Frame: Baseline and Week 4 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Functional Residual Capacity [ Time Frame: 4 weeks ]
Change from baseline in trough Functional Residual capacity (FRC) after 4 weeks of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8 [ Time Frame: Baseline to Week 8 ]
    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.
  • Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8 [ Time Frame: Week 8 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Endurance Time [ Time Frame: 8 weeks ]
    Change from baseline in Endurance Time (ET) during constant work rate cycle ergometry to symptom limitation at 75% of Wmax after 8 weeks of treatment.
  • Percentage of Inactive Patients [ Time Frame: 8 weeks ]
    Percentage of inactive patients (<6000 steps per day) after 8 weeks on treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients
Official Title  ICMJE A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Aclidinium/Formoterol
    Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler
  • Drug: Placebo
    Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler
Study Arms  ICMJE
  • Experimental: Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg
    8 weeks, double blind treatment period
    Intervention: Drug: Aclidinium/Formoterol
  • Placebo Comparator: Placebo to Aclidinium/Formoterol
    8 weeks, double blind treatment period
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
267
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
268
Actual Study Completion Date  ICMJE July 25, 2016
Actual Primary Completion Date July 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females aged ≥ 40.
  2. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and < 80% of the predicted value and FEV1/FVC < 70% at Visit 1.
  3. Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
  4. Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
  5. Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
  6. Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
  7. Patients who understand and are able to follow the study procedures, are cooperative and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria:

  1. History or current diagnosis of asthma.
  2. Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
  3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
  4. Clinically significant respiratory conditions other than COPD.
  5. Use of long-term oxygen therapy (≥ 15 hours/day).
  6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
  7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
  8. Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
  9. Patients with clinically significant cardiovascular conditions.
  10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
  11. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
  12. Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
  13. Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
  14. Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
  15. Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
  16. Patients who cycled < 2 minutes or > 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
  17. Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
  18. Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
  19. Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
  20. Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
  21. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer).
  22. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
  23. Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Hungary,   Spain
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT02424344
Other Study ID Numbers  ICMJE D6570C00001
M-40464-33 ( Other Identifier: Clinical Trial Protocol Code )
2014-005318-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Menarini Group
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP