Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

NCT04078126 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: D5980C000232019-001801-26
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment

  Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose.

  baseline and 4 hours post dose after 1 week of treatment

Secondary Outcomes (8)

• Area Under the Curve for Change From Baseline in FEV1 From Area Under the Curve 0 to 4 Hours (AUC0-4 h) Following 1 Week of Treatment

  baseline and 4 hours post dose after 1 week of treatment

• Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment

  baseline and after 1 week of treatment

• Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment

  baseline and 2 hours post dose after 1 week of treatment

• Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment

  baseline and after 1 week of treatment

• Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment

  baseline and after 1 week of treatment

Study Arms (2)

Budesonide and formoterol fumarate (MDI BFF)

EXPERIMENTAL

Subject treated with MDI BFF followed by washout period

Combination Product: BFF

Symbicort Turbuhaler

ACTIVE COMPARATOR

Subject treated with Symbicort followed by washout period

Combination Product: Symbicort Turbuhaler

Interventions

BFF COMBINATION_PRODUCT

Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)

Budesonide and formoterol fumarate (MDI BFF)

Symbicort Turbuhaler COMBINATION_PRODUCT

Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)

Symbicort Turbuhaler

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.
• Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
• Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to Visit 1.
• A post-bronchodilator FEV1/FVC of \<0.70 and post-bronchodilator FEV1 of \<50% predicted normal value at Visit 2.
• A pre-bronchodilator PIF of \<50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit 2.
• Current or former smokers with history of at least 10 pack-years of cigarette smoking.

You may not qualify if:

• Current diagnosis of asthma, in the opinion of the Investigator.
• Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
• A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization (Visit 3).
• Need for mechanical ventilation within 3 months prior to Visit 1.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Frankfurt am Main, 60389, Germany

Location

Research Site

Gauting, 82131, Germany

Location

Research Site

Hanover, D-30173, Germany

Location

Research Site

Landsberg, 86899, Germany

Location

Related Publications (1)

• Huber B, Keller C, Jenkins M, Raza A, Aurivillius M. Effect of inhaled budesonide/formoterol fumarate dihydrate delivered via two different devices on lung function in patients with COPD and low peak inspiratory flow. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107312. doi: 10.1177/17534666221107312.

  PMID: 35815354 DERIVED

Related Links

• The CSP redacted.
• the SAP redacted.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: AstraZeneca AB
• Organization: AstraZeneca AB

information.center@astrazeneca.com

877-240-9479

Study Officials

• Bärbel Huber, Dr.

  2601

  PRINCIPAL INVESTIGATOR

• Heiner Steffen, Dr.

  2602

  PRINCIPAL INVESTIGATOR

• Claus Keller, Dr.

  2603

  PRINCIPAL INVESTIGATOR

• Martin Hoffmann, Dr.

  2604

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 4, 2019
• Study Start: September 10, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

DE (4)