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Phase 4 Completed N=198 Randomized Double-blind Treatment

A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02275052 ↗
Enrolled (actual)
198
Serious AEs
2.5%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline in Exercise Endurance Time (EET) Post-dose at Week 12 of Each Treatment Period — -2.06; -5.37 Seconds (s) — p=0.790
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block design cross-over study. The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will be characterized. Approximately 298 participants will be screened and, assuming 35% of these will not be eligible for randomization; approximately 194 participants will be randomized. Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1 participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI 62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out period of 12-17 days. The total duration of patient participation, including the Follow-Up will be approximately 30 weeks. All participants will be provided with albuterol for use on an "as needed (prn)" basis throughout the run-in, washout and study treatment periods while on investigational product.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Exercise Endurance Time (EET) Post-dose at Week 12 of Each Treatment Period
-2.06; -5.37 0.790
SECONDARY
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period
0.173; -0.034 <0.001 sig
SECONDARY
Change From Baseline in Functional Residual Capacity (FRC) 3 Hours Post-dose at Week 12 of Each Treatment Period
-0.457; -0.111 <0.001 sig
SECONDARY
Change From Baseline in Inspiratory Capacity (IC) 3 Hours Post-dose at Week 12 of Each Treatment Period
0.225; -0.034 <0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Type of participant: Outpatient.
  • Informed Consent: A signed and dated written informed consent prior to study participation.
  • Age: 40 years of age or older at Visit 1.
  • Gender: Male or female participants. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS) that meets the standard operating procedures (SOP); effectiveness criteria as stated in the product label; Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female participant's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the participant or review of the participant's medical history for study eligibility, as obtained via a verbal interview with the participant or from the participant's medical records; Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • Diagnosis: A diagnosis of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
  • Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years (number of pack years =[number of cigarettes per day /20] x number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
  • Severity of Disease: A pre- and post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) ratio of =30% and =2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.
  • Resting Lung Volumes: A resting FRC of >=120% of predicted normal FRC at Visit 1. Predicted values for FRC will be obtained using predicted normal values

Exclusion Criteria

  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: A current diagnosis of asthma.
  • Other Respiratory Disorders Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer in remission for 120 beats per minute (bpm); Sustained or nonsustained ventricular tachycardia; Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted)
  • Medication Prior to Spirometry: Unable to withhold albuterol for the 4 hour period required prior to spirometry testing at each study visit
  • Interactions: Concomitant administration with beta-blockers or strong Cytochrome P450 3A4 (CYP3A4) inhibitors is only permitted if, in the Investigator's opinion, the likely benefit outweighs the potential risk
  • Medications prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids (12
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02275052). 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.

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