Loading clinical trials...

COMPLETEDPHASE1

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)

NCT02474017•Mylan Pharma UK Ltd.

View on ClinicalTrials.gov

Summary

To confirm the robustness of the CRC749 inhaler.

Eligibility

Age

12 - No limit years

Sex

ALL

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.

Locations (2)

Mylan Investigational Site

London, United Kingdom

Mylan Investigational Site

Manchester, United Kingdom

Key Dates

Start Date

May 1, 2015

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

March 7, 2022

Enrollment

111

ACTUAL participants

Conditions

AsthmaCOPD

Interventions

MGR001

DRUG

CRC749 inhaler

DEVICE

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open Study to Assess the Robustness of the CRC749 Inhaler

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

cfMSC Stem Cell Therapy Targeting COPD