AsthmaNCT01033669
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
An observational study of Asthma and Pulmonary Disease, Chronic Obstructive, run by Pfizer at 1 site in Germany.
Trial summary
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- CRC-749, Diskus and Twisthaler
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Feb 2010
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma and COPD patients
Who may be able to join
- Subjects with a physician documented history or diagnosis of asthma for at least 6 months
- Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
- Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease
Who cannot join
- Female subjects who are pregnant
- Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
- Evidence of lower respiratory tract infection
- Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
Read the detailed description
Randomized to device sequence
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Being tested
- CRC-749, Diskus, Twisthaler, Miat Monohaler
- Keywords
- Inhalation profiles, asthma, COPD
- 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.
CRC-749Device
There is no drug being used. This is a device.
DiskusDevice
There is no drug being used. This is a device.
TwisthalerDevice
There is no drug being used. This is a device.
Miat MonohalerDevice
There is no drug being used. This is a device.
| Study group | Role | What they receive |
|---|---|---|
| Dry Powder Inhalers | Not described Receives: Device: CRC-749; Device: Diskus; Device: Twisthaler; Device: Miat Monohaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Inspiratory Flow Rate
Measured: Day 3-10
Secondary outcomes (4)
Pressure Slope
Measured: Day 3-10
Peak Pressure Drop
Measured: Day 3-10
Time to Peak Pressure Drop
Measured: Day 3-10
Inhaled Volume
Measured: Day 3-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033669
- Sponsor's protocol ID
- A9011071
- Status last verified
- Mar 2010
- First submitted
- 24 Sep 2009
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01033669
- Acronym / sponsor ID
- A9011071
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Keywords
- Inhalation profiles, asthma, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Dec 2009 (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.
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
Detailed description
Randomized to device sequence
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Powder Inhalers | – | Device: CRC-749, Device: Diskus, Device: Twisthaler, Device: Miat Monohaler |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma and COPD patients
Key inclusion criteria (3 listed)
- Subjects with a physician documented history or diagnosis of asthma for at least 6 months
- Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
- Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease
Key exclusion criteria (4 listed)
- Female subjects who are pregnant
- Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
- Evidence of lower respiratory tract infection
- Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis
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 |
|---|---|---|
| CRC-749There is no drug being used. This is a device. | Device | Dry Powder Inhalers |
| DiskusThere is no drug being used. This is a device. | Device | Dry Powder Inhalers |
| TwisthalerThere is no drug being used. This is a device. | Device | Dry Powder Inhalers |
| Miat MonohalerThere is no drug being used. This is a device. | Device | Dry Powder Inhalers |
Primary outcome
Peak Inspiratory Flow Rate
Time frame: Day 3-10
4 secondary outcomes
Pressure Slope
Time frame: Day 3-10
Peak Pressure Drop
Time frame: Day 3-10
Time to Peak Pressure Drop
Time frame: Day 3-10
Inhaled Volume
Time frame: Day 3-10
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 17 Mar 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pulmonary Disease, Chronic Obstructive, run by Pfizer at 1 site in Germany.
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 3 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 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Peak Inspiratory Flow Rate (time frame: Day 3-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2010.