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Completed

NCT Number: NCT02245672

MGR001 / Advair Diskus Local Equivalence Study in Asthma

The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mylan Investigative Site #1, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device

Placebo

Drug

Placebo administered via the CRC749 and Diskus devices

Primary outcomes

  1. Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)

    Time frame: 0-12 hours after dosing on Day 1

    The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo

  2. Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)

    Time frame: 0-12 hours after dosing on Day 1

    The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures

  3. FEV1 Trough Value (Assay Sensitivity)

    Time frame: Day 1 and Day 29

    Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.

  4. FEV1 Trough Value (Bioequivalence)

    Time frame: Day 1 and Day 29

    Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]

Sponsors and collaborators

Lead sponsor

Mylan Pharma UK Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Double Dummy, Parallel Group Study to Determine the Local Equivalence of Multiple Doses of MGR001 to Advair Diskus Administered Via Oral Inhalation in Adult Asthma Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2014
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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