A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Combination Product: BGF; Combination Product: GFF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03836677

D5980C00019

Details and patient eligibility

About

This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.

Full description

This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds.

This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).

Enrollment: 23 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1.

• COPD Diagnosis: Subjects with an established clinical history of COPD
• Screening clinical laboratory tests must be acceptable to the Investigator.
• Screening ECG must be acceptable to the Investigator
• Individual Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments
• Patients should be on scheduled maintenance treatment with one or more inhaled bronchodilator therapies.

Exclusion criteria

• As judged by the investigator, any evidence of significant diseases other than COPD, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial.

• Spirometry Performance:

  1. Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
  2. Repeatability: Subjects who cannot perform technically acceptable spirometry in accordance with ATS repeatability criteria

• Cancer: Subjects who have cancer that has not been in complete remission for at least five years.

• Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse alcohol or drugs

• Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

23 participants in 2 patient groups

BGF-GFF

Experimental group

Description:

Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate

Treatment:

Combination Product: GFF

Combination Product: BGF

GFF-BGF

Experimental group

Description:

Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate

Treatment:

Combination Product: GFF

Combination Product: BGF