AsthmaPhase 1NCT02474017
An Open Study to Assess the Robustness of the CRC749 Inhaler
A Phase 1 study testing MGR001 and CRC749 inhaler in people with Asthma and COPD, run by Mylan Pharma UK Ltd. at 2 sites in United Kingdom.
Trial summary
To confirm the robustness of the CRC749 inhaler. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- MGR001 and CRC749 inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Mylan Investigational Site
London
Mylan Investigational Site
Manchester
About this study
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)
To confirm the robustness of the CRC749 inhaler.
- Being tested
- MGR001, CRC749 inhaler
- Keywords
- Inhaler, Adolescent
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGR001Drug
Fluticasone Propionate / Salmeterol administered using CRC749 inhaler
CRC749 inhalerDevice
| Study group | Role | What they receive |
|---|---|---|
| MGR001 | Experimental | MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) Receives: Drug: MGR001; Device: CRC749 inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Secondary outcomes (1)
Adverse Events
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharma UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Allan, Study director, Mylan Pharma UK Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474017
- Sponsor's protocol ID
- MGR001-1010
- Other IDs
- 2015-000463-13, 2015
- Status last verified
- Feb 2022
- First submitted
- 3 Jun 2015
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32865454
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02474017
- Acronym / sponsor ID
- MGR001-1010
- Keywords
- Inhaler, Adolescent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Mylan Pharma UK Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the robustness of the CRC749 inhaler.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGR001 | Experimental | Drug: MGR001, Device: CRC749 inhalerMGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGR001Fluticasone Propionate / Salmeterol administered using CRC749 inhaler | Drug | MGR001 |
| CRC749 inhaler | Device | MGR001 |
Primary outcome
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.
1 secondary outcome
Adverse Events
Time frame: 3 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Derived from this study: PubMed 32865454Allan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Allan study director
Mylan Pharma UK Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGR001 and CRC749 inhaler in people with Asthma and COPD, run by Mylan Pharma UK Ltd. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro Measurement of Emitted Dose (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.