An Open Study to Assess the Robustness of the CRC749 Inhaler

Mylan

Status and phase: Completed; Phase 1

Conditions: Asthma; COPD

Treatments: Device: CRC749 inhaler; Drug: MGR001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02474017

2015-000463-13 (EudraCT Number)

MGR001-1010

Details and patient eligibility

About

To confirm the robustness of the CRC749 inhaler.

Enrollment: 111 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

MGR001

Experimental group

Description:

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

Treatment:

Device: CRC749 inhaler

Drug: MGR001