An Open Study to Assess the Robustness of the CRC749 Inhaler

Overview

To confirm the robustness of the CRC749 inhaler.

Full Title of Study: “An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered Via Oral Inhalation in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: MGR001
    • Fluticasone Propionate / Salmeterol administered using CRC749 inhaler
  • Device: CRC749 inhaler

Arms, Groups and Cohorts

  • Experimental: MGR001
    • MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)

Clinical Trial Outcome Measures

Primary Measures

  • In vitro Measurement of Emitted Dose
    • Time Frame: 3 Weeks
    • CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.

Secondary Measures

  • Adverse Events
    • Time Frame: 3 Weeks

Participating in This Clinical Trial

Inclusion Criteria

1. Males and females at least 12 years of age. 2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment. 3. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio <0.7 for COPD subjects. 4. Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects. 5. Ability to use the CRC749 inhaler. Exclusion Criteria:

1. Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening. 2. History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds. 3. Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction. 4. Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mylan Inc.
  • Collaborator
    • Mylan Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Allan, Study Director, Mylan Pharmaceuticals

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