An Open Study to Assess the Robustness of the CRC749 Inhaler

NCT02474017 | Completed Phase 1

• 2 other identifiers: MGR001-10102015-000463-13
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

To confirm the robustness of the CRC749 inhaler.

Conditions

Asthma; COPD

Keywords

Inhaler; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Adverse Events

  3 Weeks

Study Arms (1)

MGR001

EXPERIMENTAL

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

Drug: MGR001; Device: CRC749 inhaler

Interventions

MGR001 DRUG

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

MGR001

CRC749 inhaler DEVICE

MGR001

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Pharma UK Ltd.: lead

Study Sites (2)

Mylan Investigational Site

London, United Kingdom

Location

Mylan Investigational Site

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32865454 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Allan

  Mylan Pharma UK Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 17, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

GB (2)