Phase 3
Completed N=1,128
MGR001 / Advair Diskus Local Equivalence Study in Asthma
Source: ClinicalTrials.gov NCT02245672 ↗Enrolled (actual)
1,128
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity) — 3.9534; 3.4964; 0.8191 L*hr — p=<0.0001
◆ Published Evidence
Emerging
16citations · ~3 / year
Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma.
Summary
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients
Linked Publications
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Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity) |
3.9534; 3.4964; 0.8191 | <0.0001 sig |
| PRIMARY Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence) |
3.9734; 3.5411; 0.8400 | — |
| PRIMARY FEV1 Trough Value (Assay Sensitivity) |
0.2927; 0.2720; 0.0575 | <0.0001 sig |
| PRIMARY FEV1 Trough Value (Bioequivalence) |
0.2911; 0.2728; 0.0574 | — |
Eligibility Criteria
Key inclusion criteria include:
- Male or female subjects aged ≥18 years. Females may be of either childbearing or non-childbearing potential
- Physician diagnosed history of asthma for at least 12 weeks prior to screening
- pre-bronchodilator FEV1 60-85% at screening and other specified visits
- Post-bronchodilator reversibility >/=12%
- Non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
- Subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
- Body mass index between 18-40 kg/m2 inclusive
Key exclusion criteria include:
- Presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
- Respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
- History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
- In patient hospitalization (not including ER visits) for an asthma exacerbation within the past year or during the run in period
- An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids in the 3 months prior to screening
- History of seasonally unstable asthma where the season will coincide with the subject's participation in the study
- Use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
- Suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
- Clinically significant abnormalities in the screening ECG
- Evidence of alcohol or drug abuse or dependency within 6 months prior to screening
Data sourced from ClinicalTrials.gov (NCT02245672) 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.