An Open Study to Assess the Robustness of the CRC749 Inhaler

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To confirm the robustness of the CRC749 inhaler.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan Pharmaceuticals

Criteria

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.