An Open Study to Assess the Robustness of the CRC749 Inhaler
- Registration Number
- NCT02474017
- Lead Sponsor
- Mylan Pharma UK Ltd.
- Brief Summary
To confirm the robustness of the CRC749 inhaler.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
- Males and females at least 12 years of age.
- A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment.
- Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio <0.7 for COPD subjects.
- Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects.
- Ability to use the CRC749 inhaler.
Exclusion Criteria
- Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening.
- History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds.
- 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.
- Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MGR001 MGR001 MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) MGR001 CRC749 inhaler MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)
- Primary Outcome Measures
Name Time Method In vitro Measurement of Emitted Dose 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 Outcome Measures
Name Time Method Adverse Events 3 Weeks
Trial Locations
- Locations (1)
Mylan Investigational Site
🇬🇧Manchester, United Kingdom