AsthmaticPhase 2NCT01738087
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
A Phase 2 study testing NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg and NEXThaler 200/6 mcg DPI in people with Asthmatic, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthmatic
- What is being tested?
- NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg and NEXThaler 200/6 mcg DPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Jan 2013
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
- Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
- Patients with Forced Expiratory Volume in 1 sec (FEV1) >= 70 % of predicted values
- Non or ex-smokers
- Body Mass Index (BMI) >= 18.5 and <= 32 kg/m2
Who cannot join
- Pregnant or lactating women unless using acceptable methods of contraception
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- History of near fatal asthma
- Patients with abnormal QTcF at screening Visit
- Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
- Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
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- History of drug addiction or excessive use of alcohol ;
- Diagnosis of restrictive lung disease.
- Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
- Significant medical history or any laboratory abnormality indicative of a significant underlying condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.
At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
- Conditions
- Asthmatic
- Being tested
- NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg, NEXThaler 200/6 mcg DPI, NEXThaler placebo
- Keywords
- patients, Adult
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEXThaler 100/6 mcg DPIDrug
Also called Fixed combination of BDP plus formoterol fumarate
Flixotide Accuhaler 500 mcgDrug
Also called Fluticasone Propionate
Active comparator
NEXThaler 200/6 mcg DPIDrug
Also called Fixed combination of BDP plus formoterol fumarate
NEXThaler placeboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| NEXThaler 100/6 mcg DPI | Experimental | Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg Receives: Drug: NEXThaler 100/6 mcg DPI |
| NEXThaler 200/6 mcg DPI | Experimental | Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg Receives: Drug: NEXThaler 200/6 mcg DPI |
| NEXThaler placebo | Placebo comparator | Single dose (4 inhalations) Receives: Drug: NEXThaler placebo |
| NEXThaler 100/6 mcg plus CB | Experimental | Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg Receives: Drug: NEXThaler 100/6 mcg DPI |
| NEXThaler 200/6 mcg plus CB | Experimental | Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg Receives: Drug: NEXThaler 200/6 mcg DPI |
| Flixotide Accuhaler 500 mcg | Active comparator | Single dose (2 inhalations) of fluticasone propionate Receives: Drug: Flixotide Accuhaler 500 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formoterol AUC0-t and B17MP AUC0-t
Measured: from predose until 12 hr post dose
Secondary outcomes (2)
BDP pharmacokinetic (PK) parameters
The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2
Measured: from predose until 12 hr post dose
Other PK parameter of B17MP and formoterol
the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2
Measured: from predose until 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738087
- Sponsor's protocol ID
- CCD-1205-PR-0087
- Other IDs
- 2012-002370-30
- Status last verified
- Oct 2021
- First submitted
- 15 Nov 2012
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT01738087
- Acronym / sponsor ID
- CCD-1205-PR-0087
- Conditions
- Asthmatic
- Keywords
- patients, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Nov 2012 (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 study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.
At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NEXThaler 100/6 mcg DPI | Experimental | Drug: NEXThaler 100/6 mcg DPISingle dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg |
| NEXThaler 200/6 mcg DPI | Experimental | Drug: NEXThaler 200/6 mcg DPISingle dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg |
| NEXThaler placebo | Placebo comparator | Drug: NEXThaler placeboSingle dose (4 inhalations) |
| NEXThaler 100/6 mcg plus CB | Experimental | Drug: NEXThaler 100/6 mcg DPISingle dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg |
| NEXThaler 200/6 mcg plus CB | Experimental | Drug: NEXThaler 200/6 mcg DPISingle dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg |
| Flixotide Accuhaler 500 mcg | Active comparator | Drug: Flixotide Accuhaler 500 mcgSingle dose (2 inhalations) of fluticasone propionate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
- Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
- Patients with Forced Expiratory Volume in 1 sec (FEV1) >= 70 % of predicted values
- Non or ex-smokers
- Body Mass Index (BMI) >= 18.5 and <= 32 kg/m2
Key exclusion criteria (10 listed)
- Pregnant or lactating women unless using acceptable methods of contraception
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- History of near fatal asthma
- Patients with abnormal QTcF at screening Visit
- Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
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 |
|---|---|---|
| NEXThaler 100/6 mcg DPIAlso: Fixed combination of BDP plus formoterol fumarate | Drug | NEXThaler 100/6 mcg DPI, NEXThaler 100/6 mcg plus CB |
| Flixotide Accuhaler 500 mcgAlso: Fluticasone PropionateActive comparator | Drug | Flixotide Accuhaler 500 mcg |
| NEXThaler 200/6 mcg DPIAlso: Fixed combination of BDP plus formoterol fumarate | Drug | NEXThaler 200/6 mcg DPI, NEXThaler 200/6 mcg plus CB |
| NEXThaler placeboPlacebo comparator | Drug | NEXThaler placebo |
Primary outcome
Formoterol AUC0-t and B17MP AUC0-t
Time frame: from predose until 12 hr post dose
2 secondary outcomes
BDP pharmacokinetic (PK) parameters
Time frame: from predose until 12 hr post dose
Other PK parameter of B17MP and formoterol
Time frame: from predose until 12 hours postdose
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg and NEXThaler 200/6 mcg DPI in people with Asthmatic, run by Chiesi Farmaceutici S.p.A. at 1 site 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 10 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 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. 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.
What does this phase mean?
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?
Formoterol AUC0-t and B17MP AUC0-t (time frame: from predose until 12 hr post dose). 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 29 Oct 2021.