Pulmonary Disease, Chronic ObstructivePhase 1/2NCT01176747
Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients
A Phase 1/2 study testing BDP/formoterol NEXT DPI in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma
- What is being tested?
- BDP/formoterol NEXT DPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Oct 2010
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Males and females aged 18-65 years;
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;
- Normal blood pressure and heart rate;
- Normal electrocardiogram (ECG,12 lead);
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- Normal laboratory tests;
- Patients with Asthma:
- Males and females aged 21-65 years;
- BMI between 18.0 and 28.0 kg/m2;
- Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;
- Normal blood pressure and heart rate;
- Normal ECG (12 lead);
- FEV1 ≥ 30% and < 80% of predicted according to European Coal and Steel Community values (ECSC)
- Reversibility of FEV1 ≥ 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol;
- Patients with COPD:
- Males and females aged 40 - 70 years
- BMI between 18.0 and 30.0 kg/m2;
- Normal blood pressure and heart rate;
- Normal ECG (12 lead);
- Stable COPD within the past 4 weeks;
- Post bronchodilator FEV1 between 30% and 50% predicted values (ECSC);
- Post bronchodilator FEV1/FVC < 0.70 (absolute value);
- Minimum smoking history of 10 pack-years;
Who cannot join
- All subjects:
- Blood donation or blood loss in the previous 8 weeks;
- Positive HIV1 or HIV2 serology;
- Positive acute or chronic Hepatitis B or Hepatitis C;
- Unsuitable veins for repeated venipuncture;
- Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception.
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- History of substance abuse or positive urine drug screen;
- Abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
- Uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric clinically significant disorder;
- Participation in another clinical trial in the previous 8 weeks; participation in study using radioactive material within 1 calendar year;
- Known sensitivity to Formoterol or Beclometasone or any of the excipients;
- Concomitant severe diseases or diseases which are contra indications for the use of inhaled Beta-2-agonist or steroids;
- Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;
- Recent relevant infectious disease (less than two months);
- Flu vaccination or other vaccination within 4 weeks prior to the screening visit;
- Additional exclusion criteria for healthy volunteers:
- Lung function measurements outside normal limits (normal values: FEV1/FVC > 0.70 and FEV1 and FVC > 80% for the ECSC predicted values);
- Additional exclusion criteria for patients with Asthma:
- Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
- Life-threatening/unstable respiratory status within the previous 30 days;
- Requirement of supplemental oxygen therapy;
- Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit;
- Asthma exacerbation within the 4 weeks prior to inclusion.
- Additional exclusion criteria for patients with COPD:
- Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
- Life-threatening/unstable respiratory status within the previous 30 days;
- Requirement of supplemental oxygen therapy;
- Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit;
- COPD exacerbation within the 4 weeks prior to inclusion;
- History of asthma or any chronic respiratory diseases other than COPD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-vivo Deposition Measurement of Beclometasone and Formoterol After Inhalation of a Single Dose of the Combination BDP Plus Formoterol NEXT DPI in Healthy Volunteers, Asthmatic and COPD Patients.
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma
- Being tested
- BDP/formoterol NEXT DPI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDP/formoterol NEXT DPIDrug
Also called CHF 1535 NEXT DPI
Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
| Study group | Role | What they receive |
|---|---|---|
| BDP/formoterol NEXT DPI | Experimental | Radiolabelled BDP/formoterol 100/6 µg dry powder administered via the NEXT inhaler Receives: Drug: BDP/formoterol NEXT DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler
Calculated using the individual Gamma camera images and the regions of interest defined from the 81mKrypton-ventilation scan.
Measured: Immediately after dosing
Secondary outcomes (5)
Distribution of lung deposition
Measured: Immediately after dosing
Extrathoracic deposition
Measured: Immediately after dosing
Exhaled activity
Measured: Immediately after dosing
Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP)
Measured: over 24 h post dose
Lung function parameters
Measured: over 24 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionOct 2010
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 Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Meyer, MD, Principal investigator, Inamed Research GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176747
- Sponsor's protocol ID
- CCD-0815-PR-0011
- Other IDs
- 2009-010267-17, 2009
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2010
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.
PubMed 29989511
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Deposition Measurement of Beclometasone and Formoterol After Inhalation of a Single Dose of the Combination BDP Plus Formoterol NEXT DPI in Healthy Volunteers, Asthmatic and COPD Patients.
- ClinicalTrials.gov ID
- NCT01176747
- Acronym / sponsor ID
- CCD-0815-PR-0011
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Aug 2010 (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.
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BDP/formoterol NEXT DPI | Experimental | Drug: BDP/formoterol NEXT DPIRadiolabelled BDP/formoterol 100/6 µg dry powder administered via the NEXT inhaler |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Males and females aged 18-65 years;
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;
- Normal blood pressure and heart rate;
- Normal electrocardiogram (ECG,12 lead);
Key exclusion criteria (30 listed)
- Blood donation or blood loss in the previous 8 weeks;
- Positive HIV1 or HIV2 serology;
- Positive acute or chronic Hepatitis B or Hepatitis C;
- Unsuitable veins for repeated venipuncture;
- Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception.
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 |
|---|---|---|
| BDP/formoterol NEXT DPIAlso: CHF 1535 NEXT DPISingle inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol) | Drug | BDP/formoterol NEXT DPI |
Primary outcome
Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler
Time frame: Immediately after dosing
Calculated using the individual Gamma camera images and the regions of interest defined from the 81mKrypton-ventilation scan.
5 secondary outcomes
Distribution of lung deposition
Time frame: Immediately after dosing
Extrathoracic deposition
Time frame: Immediately after dosing
Exhaled activity
Time frame: Immediately after dosing
Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP)
Time frame: over 24 h post dose
Lung function parameters
Time frame: over 24 h post dose
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 29 Oct 2021.
- Results publication: PubMed 29989511Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.
- Study Record on EU Clinical Trials Register including resultsLink 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.
Thomas Meyer, MD principal investigator
Inamed Research GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BDP/formoterol NEXT DPI in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Chiesi Farmaceutici S.p.A. 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 24 inclusion and 30 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 29 Oct 2021. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler (time frame: Immediately after dosing). 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 NCT01176747, 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 29 Oct 2021.