An Open Study to Assess the Robustness of the CRC749 Inhaler

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02474017

Enrollment

111

Registered

2015-06-17

Start date

2015-05-31

Completion date

2015-06-30

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

Keywords

Inhaler, Adolescent

Brief summary

To confirm the robustness of the CRC749 inhaler.

Interventions

DRUGMGR001

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

DEVICECRC749 inhaler

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
In vitro Measurement of Emitted Dose	3 Weeks	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

Measure	Time frame
Adverse Events	3 Weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026