Phase 4
Completed N=267
Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02424344 ↗
Enrolled (actual)
267
Serious AEs
1.9%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment — -0.162; -0.037 Liters — p=0.069
◆ Published Evidence
Emerging
5citations · ~1 / year
Differential Outcomes Following 4 Weeks of Aclidinium/Formoterol in Patients with COPD: A Reanalysis of the ACTIVATE Study.
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.
Linked Publications
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Differential Outcomes Following 4 Weeks of Aclidinium/Formoterol in Patients with COPD: A Reanalysis of the ACTIVATE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment |
-0.162; -0.037 | 0.069 |
| SECONDARY Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8 |
50.7; -4.6 | — |
| SECONDARY Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8 |
41.53; 50.43 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
- Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
- Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
- Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
- 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.
- 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).
- Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
- Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients
Data sourced from ClinicalTrials.gov (NCT02424344) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.