An Open Study to Assess the Robustness of the CRC749 Inhaler | NCT02474017

Studies
An Open Study to Assess the Robustness of the CRC749 Inhaler

NCT02474017

Sponsor

Mylan Pharma UK Ltd.

Status

Completed

Last Update Posted

Mar 7, 2022Actual

Enrollment

111Actual

Phase

Phase 1

Conditions

Asthma
COPD

Interventions

MGR001
CRC749 inhaler

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-000463-13	EudraCT Number

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 16, 2015

First Posted Date

Jun 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2022

Last Update Posted Date

Mar 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MGR001	Experimental	MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)	Drug: MGR001 Device: CRC749 inhaler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MGR001	Drug	Fluticasone Propionate / Salmeterol administered using CRC749 inhaler	MGR001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Adverse Events		3 Weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Allan	Mylan Pharma UK Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mylan Investigational Site		London			United Kingdom
Mylan Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32865454	Derived	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.

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases