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OpenTrials
Completed

NCT Number: NCT02474017

An Open Study to Assess the Robustness of the CRC749 Inhaler

To confirm the robustness of the CRC749 inhaler.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mylan Investigational Site, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MGR001

Drug

Fluticasone Propionate / Salmeterol administered using CRC749 inhaler

CRC749 inhaler

Device

Primary outcomes

  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 outcomes

  1. Adverse Events

    Time frame: 3 Weeks

Sponsors and collaborators

Lead sponsor

Mylan Pharma UK Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2015
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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