ACOS (Fixed Airflow Obstruction and Elevated Eosinophils)Phase 2/3NCT02693769
A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils
A Phase 2/3 study testing fluticasone propionate/formoterol fumarate breath actuated inhaler and Indacaterol maleate / glycopyrronium bromide capsules in people with ACOS (Fixed Airflow Obstruction and Elevated Eosinophils), run by Mundipharma Research Limited at 1 site in Slovakia.
Trial summary
The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated inhaler is effective and well tolerated in the treatment of subjects with fixed airflow obstruction and elevated eosinophils. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- ACOS (Fixed Airflow Obstruction and Elevated Eosinophils)
- What is being tested?
- fluticasone propionate/formoterol fumarate breath actuated inhaler and Indacaterol maleate / glycopyrronium bromide capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSlovakia
- Study dates
- Jul 2016to Dec 2016
- Phase
- Phase 2/3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 40 years at Screening visit.
- Adequate contraception:
- Diagnosis of fixed airflow obstruction with elevated eosinophils
- Subjects symptomatic at Visit 1 (CAT ≥10) despite currently receiving treatment with either LAMA or LABA monotherapy or LAMA + LABA as a combination inhaler or separate inhalers.
- Documented history of ≥ 1 moderate or severe respiratory disease exacerbations (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation) in the previous year.
- Willing and able to replace current therapy for obstructive lung disease with study medication.
- Able to demonstrate correct use of a BAI, Breezehaler and pMDI.
Who cannot join
- Respiratory disease exacerbation between 4 weeks prior to screening and Visit 3 (Randomisation).
- Previous treatment with ICS.
- Documented evidence of α1-antitrypsin deficiency.
- Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
- Use of long-term oxygen therapy (LTOT) at least 12 hours daily or mechanical ventilation.
- Chest X-ray or CT scans performed prior to screening which reveal evidence of clinically significant abnormalities reflective of active disease not believed to be due to COPD
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- Evidence of uncontrolled cardiovascular disease.
- Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
- Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
- Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
- Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
- Known or suspected history of drug or alcohol abuse in the last 2 years.
- Requiring treatment with any of the prohibited concomitant medications.
- Known or suspected hypersensitivity or contraindication to any of the study drugs or excipients.
- Received an investigational drug within 30 days of the Screening.
- Received a systemic corticosteroid within 30 days of the Screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Blind, Cross-over Study to Compare a Fixed Dose Combination of Fluticasone Propionate / Formoterol Fumarate (Breath Actuated Inhaler (BAI)) With a Fixed Dose Combination of Indacaterol Maleate / Glycopyrronium Bromide (Ultibro® Breezhaler) in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils
The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated inhaler is effective and well tolerated in the treatment of subjects with fixed airflow obstruction and elevated eosinophils.
Read the detailed description
The study is designed to provide efficacy and safety data for the use of fluticasone/formoterol Breath actuated inhaler in subjects with the characteristics of fixed airflow obstruction and elevated eosinophils. These patients have typically been excluded from previous Flutiform pMDI asthma and chronic obstructive pulmonary disease (COPD) trials; for example in asthma studies, patients with a smoking history of 10 pack years or more have been excluded, conversely in COPD studies patients with any prior history of asthma have been excluded. It is expected that the data from this study will provide a greater understanding of the effects of fluticasone/formoterol in this patient population
- Being tested
- fluticasone propionate/formoterol fumarate breath actuated inhaler, Indacaterol maleate / glycopyrronium bromide capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone propionate/formoterol fumarate breath actuated inhalerDrug
Indacaterol maleate / glycopyrronium bromide capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| fluticasone/formoterol BAI | Experimental | To compare the efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) Receives: Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler; Drug: Indacaterol maleate / glycopyrronium bromide capsules |
| Ultibro Breezhaler | Active comparator | Ultibro Breezhaler 85/43 µg (1 puff o.d.) Receives: Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler; Drug: Indacaterol maleate / glycopyrronium bromide capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the percentage of eosinophils in induced sputum
Measured: at Week 6 of each treatment
Secondary outcomes (1)
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the serum concentration of surfactant protein D (SPD)
Measured: at Week 6 of each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionDec 2016
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACOS (Fixed Airflow Obstruction and Elevated Eosinophils)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693769
- Sponsor's protocol ID
- KFL3503
- Status last verified
- Aug 2016
- First submitted
- 8 Feb 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Blind, Cross-over Study to Compare a Fixed Dose Combination of Fluticasone Propionate / Formoterol Fumarate (Breath Actuated Inhaler (BAI)) With a Fixed Dose Combination of Indacaterol Maleate / Glycopyrronium Bromide (Ultibro® Breezhaler) in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils
- ClinicalTrials.gov ID
- NCT02693769
- Acronym / sponsor ID
- KFL3503
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Feb 2016 (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 whether fluticasone/formoterol Breath actuated inhaler is effective and well tolerated in the treatment of subjects with fixed airflow obstruction and elevated eosinophils.
Detailed description
The study is designed to provide efficacy and safety data for the use of fluticasone/formoterol Breath actuated inhaler in subjects with the characteristics of fixed airflow obstruction and elevated eosinophils. These patients have typically been excluded from previous Flutiform pMDI asthma and chronic obstructive pulmonary disease (COPD) trials; for example in asthma studies, patients with a smoking history of 10 pack years or more have been excluded, conversely in COPD studies patients with any prior history of asthma have been excluded. It is expected that the data from this study will provide a greater understanding of the effects of fluticasone/formoterol in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone/formoterol BAI | Experimental | Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler, Drug: Indacaterol maleate / glycopyrronium bromide capsulesTo compare the efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) |
| Ultibro Breezhaler | Active comparator | Drug: fluticasone propionate/formoterol fumarate breath actuated inhaler, Drug: Indacaterol maleate / glycopyrronium bromide capsulesUltibro Breezhaler 85/43 µg (1 puff o.d.) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged ≥ 40 years at Screening visit.
- Adequate contraception:
- Diagnosis of fixed airflow obstruction with elevated eosinophils
- Subjects symptomatic at Visit 1 (CAT ≥10) despite currently receiving treatment with either LAMA or LABA monotherapy or LAMA + LABA as a combination inhaler or separate inhalers.
- Documented history of ≥ 1 moderate or severe respiratory disease exacerbations (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation) in the previous year.
Key exclusion criteria (16 listed)
- Respiratory disease exacerbation between 4 weeks prior to screening and Visit 3 (Randomisation).
- Previous treatment with ICS.
- Documented evidence of α1-antitrypsin deficiency.
- Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
- Use of long-term oxygen therapy (LTOT) at least 12 hours daily or mechanical ventilation.
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 |
|---|---|---|
| fluticasone propionate/formoterol fumarate breath actuated inhaler | Drug | Ultibro Breezhaler, fluticasone/formoterol BAI |
| Indacaterol maleate / glycopyrronium bromide capsules | Drug | Ultibro Breezhaler, fluticasone/formoterol BAI |
Primary outcome
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the percentage of eosinophils in induced sputum
Time frame: at Week 6 of each treatment
1 secondary outcome
The efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the serum concentration of surfactant protein D (SPD)
Time frame: at Week 6 of each treatment.
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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 2/3 study testing fluticasone propionate/formoterol fumarate breath actuated inhaler and Indacaterol maleate / glycopyrronium bromide capsules in people with ACOS (Fixed Airflow Obstruction and Elevated Eosinophils), run by Mundipharma Research Limited at 1 site in Slovakia.
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 16 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: stopped early, as of the sponsor's last update on 12 Dec 2016. 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 Slovakia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Recruitment issues). Results are not available in the source record.
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 efficacy of fluticasone/formoterol BAI 125/5 μg (2 puffs b.i.d.) versus Ultibro Breezhaler 85/43 µg (1 puff o.d.) in terms of the percentage of eosinophils in induced sputum (time frame: at Week 6 of each treatment). 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 12 Dec 2016.