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An Open Study to Assess the Robustness of the CRC749 Inhaler

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ClinicalTrials.gov Identifier: NCT02474017
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : September 28, 2015
Sponsor:
Collaborator:
Mylan Pharmaceuticals
Information provided by (Responsible Party):
Mylan Inc.

Brief Summary:
To confirm the robustness of the CRC749 inhaler.

Condition or disease Intervention/treatment Phase
Asthma COPD Drug: MGR001 Device: CRC749 inhaler Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MGR001
MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)
Drug: MGR001
Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

Device: CRC749 inhaler



Primary Outcome Measures :
  1. In vitro Measurement of Emitted Dose [ Time Frame: 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 Outcome Measures :
  1. Adverse Events [ Time Frame: 3 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474017


Locations
United Kingdom
Mylan Investigational Site
London, United Kingdom
Mylan Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Mylan Inc.
Mylan Pharmaceuticals
Investigators
Study Director: Richard Allan Mylan Pharmaceuticals

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02474017     History of Changes
Other Study ID Numbers: MGR001-1010
2015-000463-13 ( EudraCT Number )
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Mylan Inc.:
Inhaler
Adolescent

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases