Phase 3
Completed N=138
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
Source: ClinicalTrials.gov NCT02268396 ↗Enrolled (actual)
138
Serious AEs
2.2%
Results posted
Dec 2016
Primary outcomePrimary: Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count — 96.4 Percentage
◆ Published Evidence
Emerging
3citations · ~0 / year
An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease.
Summary
This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.
Linked Publications
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An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count |
96.4 | — |
| SECONDARY Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit |
86.9 | — |
| SECONDARY Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit |
96.2 | — |
| SECONDARY Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit. |
75.0 | — |
| SECONDARY Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount) |
2.9 | — |
| SECONDARY Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count |
87.3; 93.2 | — |
Eligibility Criteria
Inclusion Criteria
- Give their signed written informed consent to participate.
- Are at least 40 years of age and no older than 80 at Visit 1.
- A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
- COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS).
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- FEV1/FVC ratio of <0.70.
- Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
- Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
Exclusion Criteria
- Pregnancy, nursing females or subjects trying to conceive.
- Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
- Current primary diagnosis of asthma.
- History of ECG abnormalities.
- Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
- Clinically significant bladder neck obstruction or urinary retention.
- Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
- Cancer that has not been in complete remission for at least five years.
- Inadequately treated glaucoma.
- History of allergic reaction or hypersensitivity to any component of the formulations used in this study.
Data sourced from ClinicalTrials.gov (NCT02268396) 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.