An Open Study to Assess the Robustness of the CRC749 Inhaler

Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474017
• Other study ID #: MGR001-1010
• Secondary ID: 2015-000463-13
• Status: Completed
• Phase: Phase 1
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To confirm the robustness of the CRC749 inhaler.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

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

Device:
• CRC749 inhaler

Locations

Country	Name	City	State
United Kingdom	Mylan Investigational Site	London
United Kingdom	Mylan Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Pharma UK Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro Measurement of Emitted Dose	CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.	3 Weeks
Secondary	Adverse Events		3 Weeks