Healthy VolunteerTIOPIFNCT04147572
Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler
A study of Healthy Volunteer and COPD, run by Orion Corporation, Orion Pharma at 1 site in Estonia.
Trial summary
The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, COPD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Nov 2019to 13 Jan 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent (IC) obtained.
- ≥18 years of age.
- Documented diagnosis of COPD.
- Written informed consent (IC) obtained.
- ≥18 years of age.
- FEV1 at least 80% of the predicted value measured at screening.
- Good general health ascertained by medical history.
Who cannot join
- Any chronic respiratory disease other than COPD.
- Acute respiratory infection.
- Concurrent participation in a clinical drug study.
- Any medical condition (e.g. contraindications to spirometry) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she participates in the study. E.g. any concomitant disease in clinically labile state judged by the investigator.
- Severe milk allergy (lactose contains small amounts of milk proteins).
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease within the previous 2 years.
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- Acute respiratory infection.
- Concurrent participation in a clinical drug study.
- Any medical condition (e.g. contraindications to spirometry) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she participates in the study.
- Severe milk allergy (lactose contains small amounts of milk proteins).
- Substudy:
- Patients with documented diagnosis of COPD aged 18 year or older participating the main study will be enrolled in this substudy. Written informed consent (IC) will be obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Flow Parameters With Placebo Tiotropium Easyhaler® and Placebo Spiriva® Capsule Via HandiHaler® in Patients With COPD and in Healthy Volunteers. Substudy: Easyhaler® and HandiHaler® Usability Study in Patients With COPD
The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers.
Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.
Read the detailed description
This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers. The primary objective is to characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. The secondary objective is to calculate correlation of peak inspiratory flow (PIF) rate with regards to anthropometric and lung function parameters.
Substudy: This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers.There will be 1 study visit per subject, usually this visit is done at the same visit with the main study.
- Conditions
- Healthy Volunteer, COPD
- Being tested
- Placebo Tiotropium inhalation powder type A, Placebo Spiriva capsule, Placebo Tiotropium inhalation powder type B, Substudy Placebo Tiotropium Easyhaler, Substudy Placebo Spiriva® via HandiHaler
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Tiotropium inhalation powder type ADrug
Placebo inhalation from inhaler A
Placebo Spiriva capsuleDrug
Placebo inhalation from HandiHaler
Placebo Tiotropium inhalation powder type BDrug
Placebo inhalation from inhaler B
Substudy Placebo Tiotropium EasyhalerDevice
Substudy placebo inhalation
Substudy Placebo Spiriva® via HandiHalerDevice
Substudy placebo inhalation
| Study group | Role | What they receive |
|---|---|---|
| Inhaler A, Tiotropium Easyhaler | Experimental | Placebo Tiotropium Easyhaler, type A Receives: Drug: Placebo Tiotropium inhalation powder type A |
| Inhaler B, Tiotropium Easyhaler | Experimental | Placebo Tiotropium Easyhaler, type B Receives: Drug: Placebo Tiotropium inhalation powder type B |
| Reference product, Spiriva modified HandiHaler | Placebo comparator | Placebo Spiriva, hard capsule inhaled via modified HandiHaler device Receives: Drug: Placebo Spiriva capsule |
| Substudy Test product Placebo Tiotropium Easyhaler | Experimental | The substudy subjects will demonstrate the use of the inhaler. Receives: Device: Substudy Placebo Tiotropium Easyhaler |
| Substudy Reference product Placebo Spiriva® HandiHaler | Placebo comparator | The substudy subjects will demonstrate the use of the inhaler. Receives: Device: Substudy Placebo Spiriva® via HandiHaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.
Measured: 1 day
Secondary outcomes (1)
Inspiratory volume through the Easyhaler and HandiHaler inhalers
Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Nov 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
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 Healthy VolunteerStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Pharma Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147572
- Sponsor's protocol ID
- 3122004
- Acronym
- TIOPIF
- Status last verified
- Jan 2020
- First submitted
- 25 Oct 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.
PubMed 38170393
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Flow Parameters With Placebo Tiotropium Easyhaler® and Placebo Spiriva® Capsule Via HandiHaler® in Patients With COPD and in Healthy Volunteers. Substudy: Easyhaler® and HandiHaler® Usability Study in Patients With COPD
- ClinicalTrials.gov ID
- NCT04147572
- Acronym / sponsor ID
- TIOPIF / 3122004
- Conditions
- Healthy Volunteer, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- 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.
The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers.
Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.
Detailed description
This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers. The primary objective is to characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. The secondary objective is to calculate correlation of peak inspiratory flow (PIF) rate with regards to anthropometric and lung function parameters.
Substudy: This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers.There will be 1 study visit per subject, usually this visit is done at the same visit with the main study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Inhaler A, Tiotropium Easyhaler | Experimental | Drug: Placebo Tiotropium inhalation powder type APlacebo Tiotropium Easyhaler, type A |
| Inhaler B, Tiotropium Easyhaler | Experimental | Drug: Placebo Tiotropium inhalation powder type BPlacebo Tiotropium Easyhaler, type B |
| Reference product, Spiriva modified HandiHaler | Placebo comparator | Drug: Placebo Spiriva capsulePlacebo Spiriva, hard capsule inhaled via modified HandiHaler device |
| Substudy Test product Placebo Tiotropium Easyhaler | Experimental | Device: Substudy Placebo Tiotropium EasyhalerThe substudy subjects will demonstrate the use of the inhaler. |
| Substudy Reference product Placebo Spiriva® HandiHaler | Placebo comparator | Device: Substudy Placebo Spiriva® via HandiHalerThe substudy subjects will demonstrate the use of the inhaler. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent (IC) obtained.
- ≥18 years of age.
- Documented diagnosis of COPD.
- Written informed consent (IC) obtained.
- ≥18 years of age.
Key exclusion criteria (12 listed)
- Any chronic respiratory disease other than COPD.
- Acute respiratory infection.
- Concurrent participation in a clinical drug study.
- Any medical condition (e.g. contraindications to spirometry) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she participates in the study. E.g. any concomitant disease in clinically labile state judged by the investigator.
- Severe milk allergy (lactose contains small amounts of milk proteins).
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 |
|---|---|---|
| Placebo Tiotropium inhalation powder type APlacebo inhalation from inhaler A | Drug | Inhaler A, Tiotropium Easyhaler |
| Placebo Spiriva capsulePlacebo inhalation from HandiHaler | Drug | Reference product, Spiriva modified HandiHaler |
| Placebo Tiotropium inhalation powder type BPlacebo inhalation from inhaler B | Drug | Inhaler B, Tiotropium Easyhaler |
| Substudy Placebo Tiotropium EasyhalerSubstudy placebo inhalation | Device | Substudy Test product Placebo Tiotropium Easyhaler |
| Substudy Placebo Spiriva® via HandiHalerSubstudy placebo inhalation | Device | Substudy Reference product Placebo Spiriva® HandiHaler |
Primary outcome
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
Time frame: 1 day
After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.
1 secondary outcome
Inspiratory volume through the Easyhaler and HandiHaler inhalers
Time frame: 1 day
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 27 Jan 2020.
- Derived from this study: PubMed 38170393Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.
- Individual participant dataSharing planned: No
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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.
Orion Pharma Clinical Study Director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Volunteer and COPD, run by Orion Corporation, Orion Pharma at 1 site in Estonia.
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 7 inclusion and 12 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 27 Jan 2020. 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 Estonia. 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. Some participants in this study may receive a placebo. 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?
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers. (time frame: 1 day). 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 NCT04147572, 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 27 Jan 2020.