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Phase 3 Completed N=35 Randomized Treatment

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.

Source: ClinicalTrials.gov NCT04078126 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment — 0.256; 0.274 L — p=0.3450
◆ Published Evidence
Emerging
8citations · ~2 / year
Effect of inhaled budesonide/formoterol fumarate dihydrate delivered via two different devices on lung function in patients with COPD and low peak inspiratory flow.
Therapeutic advances in respiratory disease · 2022 · Open access · Likely link

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.

Linked Publications

  • Effect of inhaled budesonide/formoterol fumarate dihydrate delivered via two different devices on lung function in patients with COPD and low peak inspiratory flow.
    Therapeutic advances in respiratory disease · 2022 · 8 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment
0.256; 0.274 0.3450
SECONDARY
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
0.194; 0.210 0.3675
SECONDARY
Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment
0.081; 0.087 0.7563
SECONDARY
Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment
0.379; 0.411 0.5419
SECONDARY
Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment
1.50; 5.11 0.1337
SECONDARY
Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment
1.13; 3.82 0.0431 sig
SECONDARY
Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 1 Week of Treatment
1.21; 2.74 0.3625
SECONDARY
Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose
0.136; 0.093 0.0375 sig
SECONDARY
Change From Baseline in 2-hour Post-dose IC Following the First Dose
0.264; 0.258 0.9089

Eligibility Criteria

Key Inclusion Criteria

  • 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.

Key Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04078126) 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.

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