Mild Persistent AsthmaPhase 2NCT01343745
Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
A Phase 2 study testing BDP/formoterol in people with Mild Persistent Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mild Persistent Asthma
- What is being tested?
- BDP/formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Aug 2008
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients 18-50 years of age, who have signed an informed consent form.
- Clinical evidence of asthma
- Steroid naïve asthmatic patients
- FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
- Body Mass Index between 18 and 35.
- Sensitivity to AMP at Screening Visit.
- FENO levels >25 ppb at the Screening Visit
Who cannot join
- Having received an investigational product within 2 months of Screening Visit.
- Inability to comply with study procedures or with study treatment intake.
- Any significant lung disease which is considered by the investigator to be clinically significant.
- Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
- Previous or current smokers who have a smoking history greater than 5 pack years.
- Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
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- Patients with QTc >450msec at the Screening Visit.
- Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
- Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
- Patients who have undergone major surgery in the previous 3 months.
- Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
- Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
- Patients currently treated with anti-IgE Antibodies.
- Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
- Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
- Females who are pregnant, lactating or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre
London, W1G 8HU
About this study
Official title: Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO)
The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.
- Conditions
- Mild Persistent Asthma
- Being tested
- BDP/formoterol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDP/formoterolDrug
Also called Foster
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
BDP/formoterolDrug
Also called Foster
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
PlaceboDrug
pressurised metered dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pMDI Receives: Drug: Placebo |
| Low dose | Experimental | BDP/formoterol pMDI low dose Receives: Drug: BDP/formoterol |
| High dose | Experimental | BDP/Formoterol pMDI high dose Receives: Drug: BDP/formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
PC20 after AMP challenge
Provocative Concentration of AMP causing a 20% fall in FEV1.
Measured: 4 h post dose
Fractional Exhaled Nitric Oxide (FeNO)
Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma.
Measured: 4 h post dose
Lung function
FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)
Measured: from 0 to 4 h post dose
Secondary outcomes (1)
FENO
Fractional exhaled nitric oxide
Measured: 2 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 posted28 Apr 2011 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
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 Mild Persistent AsthmaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian J O'Connor, MD, Principal investigator, Heart Lung Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343745
- Sponsor's protocol ID
- FB/PS/14/169/07
- Other IDs
- 2007-004345-14
- Status last verified
- Oct 2021
- First submitted
- 21 Apr 2011
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Connor BJ, Collarini S, Poli G, Brindicci C, Spinola M, Acerbi D, Barnes PJ, Leaker B. Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial. BMC Pulm Med. 2011 Dec 21;11:60. doi: 10.1186/1471-2466-11-60.
PubMed 22188731
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
- Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO)
- ClinicalTrials.gov ID
- NCT01343745
- Acronym / sponsor ID
- FB/PS/14/169/07
- Conditions
- Mild Persistent Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Apr 2011 (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 aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pMDI |
| Low dose | Experimental | Drug: BDP/formoterolBDP/formoterol pMDI low dose |
| High dose | Experimental | Drug: BDP/formoterolBDP/Formoterol pMDI high dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female patients 18-50 years of age, who have signed an informed consent form.
- Clinical evidence of asthma
- Steroid naïve asthmatic patients
- FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
- Body Mass Index between 18 and 35.
Key exclusion criteria (17 listed)
- Having received an investigational product within 2 months of Screening Visit.
- Inability to comply with study procedures or with study treatment intake.
- Any significant lung disease which is considered by the investigator to be clinically significant.
- Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
- Previous or current smokers who have a smoking history greater than 5 pack years.
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/formoterolAlso: Fosterpressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol) | Drug | High dose |
| BDP/formoterolAlso: Fosterpressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol) | Drug | Low dose |
| Placebopressurised metered dose inhaler | Drug | Placebo |
Primary outcome
PC20 after AMP challenge
Time frame: 4 h post dose
Provocative Concentration of AMP causing a 20% fall in FEV1.
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 4 h post dose
Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma.
Lung function
Time frame: from 0 to 4 h post dose
FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)
1 secondary outcome
FENO
Time frame: 2 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 22188731O'Connor BJ, Collarini S, Poli G, Brindicci C, Spinola M, Acerbi D, Barnes PJ, Leaker B. Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial. BMC Pulm Med. 2011 Dec 21;11:60. doi: 10.1186/1471-2466-11-60.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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.
Brian J O'Connor, MD principal investigator
Heart Lung Centre
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 BDP/formoterol in people with Mild Persistent Asthma, 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 7 inclusion and 17 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?
PC20 after AMP challenge (time frame: 4 h post dose). The study lists 3 primary outcomes in all. 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 NCT01343745, 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.