NCT02424344

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2015

Geographic Reach
4 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

April 27, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

April 20, 2015

Results QC Date

July 14, 2017

Last Update Submit

December 21, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment

    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.

    Baseline and Week 4

Secondary Outcomes (2)

  • Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8

    Baseline to Week 8

  • Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8

    Week 8

Study Arms (2)

Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg

EXPERIMENTAL

8 weeks, double blind treatment period

Drug: Aclidinium/Formoterol

Placebo to Aclidinium/Formoterol

PLACEBO COMPARATOR

8 weeks, double blind treatment period

Drug: Placebo

Interventions

Aclidinium/FormoterolDRUG

Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler

Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg
PlaceboDRUG

Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler

Placebo to Aclidinium/Formoterol

Eligibility Criteria

Age40 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and non-pregnant, non-lactating females aged ≥ 40.
  • 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.
  • Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
  • Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
  • Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
  • Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
  • 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.

You may not qualify if:

  • History or current diagnosis of asthma.
  • 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.
  • Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
  • Clinically significant respiratory conditions other than COPD.
  • Use of long-term oxygen therapy (≥ 15 hours/day).
  • Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
  • Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
  • 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.
  • Patients with clinically significant cardiovascular conditions.
  • Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
  • Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
  • Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
  • 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
  • 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
  • Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Research Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Research Site

Kingston, Ontario, K7L 2V7, Canada

Location

Research Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Research Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Research Site

Berlin, 10117, Germany

Location

Research Site

Berlin, 10717, Germany

Location

Research Site

Berlin, 10787, Germany

Location

Research Site

Berlin, 10969, Germany

Location

Research Site

Berlin, 13086, Germany

Location

Research Site

Dortmund, 44263, Germany

Location

Research Site

Frankfurt, 60596, Germany

Location

Research Site

Großhansdorf, 22927, Germany

Location

Research Site

Hamburg, 20253, Germany

Location

Research Site

Hamburg, 20354, Germany

Location

Research Site

Hanover, 30173, Germany

Location

Research Site

Jena, 7740, Germany

Location

Research Site

Lübeck, 23552, Germany

Location

Research Site

München, 80331, Germany

Location

Research Site

Wiesbaden, 65187, Germany

Location

Research Site

Budapest, 1125, Hungary

Location

Research Site

Deszk, 6772, Hungary

Location

Research Site

Nyíregyháza, 4400, Hungary

Location

Research Site

Törökbálint, 2045, Hungary

Location

Research Site

Alicante, 03004, Spain

Location

Research Site

Cáceres, 10003, Spain

Location

Research Site

Madrid, 28046, Spain

Location

Related Publications (1)

  • Koopman M, Franssen FME, Gaffron S, Watz H, Troosters T, Garcia-Aymerich J, Paggiaro P, Molins E, Moya M, van Burk L, Maier D, Garcia Gil E, Wouters EFM, Vanfleteren LEGW, Spruit MA. Differential Outcomes Following 4 Weeks of Aclidinium/Formoterol in Patients with COPD: A Reanalysis of the ACTIVATE Study. Int J Chron Obstruct Pulmon Dis. 2022 Mar 8;17:517-533. doi: 10.2147/COPD.S308600. eCollection 2022.

    PMID: 35342289DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromideFormoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Results Point of Contact

Title
Study Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

April 27, 2015

Primary Completion

July 25, 2016

Study Completion

July 25, 2016

Last Updated

October 9, 2018

Results First Posted

October 9, 2018

Record last verified: 2017-12

Locations

ES(3)DE(15)HU(4)CA(4)