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An Open Study to Assess the Robustness of the CRC749 Inhaler

Primary Purpose

Asthma, COPD

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

MGR001

CRC749 inhaler

About this trial

This is an interventional treatment trial for Asthma focused on measuring Inhaler, Adolescent

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mylan Investigational Site
Mylan Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MGR001

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events

Full Information

NCT ID

NCT02474017

First Posted

June 3, 2015

Last Updated

February 22, 2022

Sponsor

Mylan Pharma UK Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02474017

Brief Title

An Open Study to Assess the Robustness of the CRC749 Inhaler

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mylan Pharma UK Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To confirm the robustness of the CRC749 inhaler.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, COPD

Keywords

Inhaler, Adolescent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MGR001

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MGR001

Intervention Description

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

Intervention Type

Device

Intervention Name(s)

CRC749 inhaler

Primary Outcome Measure Information:

Title

In vitro Measurement of Emitted Dose

Description

CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.

Time Frame

3 Weeks

Secondary Outcome Measure Information:

Title

Adverse Events

Time Frame

3 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Allan

Organizational Affiliation

Mylan Pharma UK Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Mylan Investigational Site

City

London

Country

United Kingdom

Facility Name

Mylan Investigational Site

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32865454

Citation

Allan R, Canham K, Wallace R, Singh D, Ward J, Cooper A, Newcomb C. Usability and Robustness of the Wixela Inhub Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2021 Apr;34(2):134-145. doi: 10.1089/jamp.2020.1603. Epub 2020 Aug 31.

Results Reference

derived

Learn more about this trial

An Open Study to Assess the Robustness of the CRC749 Inhaler

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