AsthmaPhase 3ANASSA-PDNCT04665895
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma
A Phase 3 study testing Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals and FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK in people with Asthma, run by Respirent Pharmaceuticals Co Ltd. at 1 site in Greece.
Trial summary
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals and FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 1 siteGreece
- Study dates
- 9 Dec 2020to 22 Feb 2022
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects (≥12 years of age) of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control.
- Patients diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP), at least 12 weeks months prior to screening (Visit 1).
- Pre-bronchodilator FEV1 of ≥45% and ≤85% of the predicted value (for age ≥18 years), or ≥65% and ≤90% predicted normal value (for ages 12 to 17 years) during the screening visit and on the first day of treatment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
- ≥12% and 200 mL reversibility of FEV1 within 30 minutes following 400 mcg salbutamol (4 puffs) inhalation (pMDI). This may be demonstrated at the Screening Visit or this test may be repeated on a different day if the patient fails the first attempt anytime in the period leading up to the day of randomization; If reversibility is not demonstrated up to the day of randomization then patients may be permitted to enter the study with historical evidence of reversibility that was performed within 2 years prior to Screening visit (Visit 1).
- Patients should be on stable doses of their chronic asthma treatment regimen and should have well-controlled asthma for at least 4 weeks prior to enrolment.
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- Patients who are able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study, according to investigator's judgement.
- Patients who are able to replace current short-acting β agonists (SABAs) with salbutamol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).
- Patients who are able to continue treatment with theophylline or montelukast without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each patient visit: 1) montelukast 36 hours 2) short-acting forms of theophylline 12 hours, 3) twice-a-day controlled-release forms of theophylline 24 hours, 4) once-a-day controlled-release forms of theophylline 36 hours.
- Patients who are able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits.
- Willing to provide voluntary written informed consent and data protection declaration (and in the case of a minor their parent/guardian was able to give) before any clinical trial related procedure is performed.
Who cannot join
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year.
- Significant respiratory disease other than asthma (COPD, interstitial lung disease, chronic bronchitis, emphysema, etc.).
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Hypersensitivity to any sympathomimetic drug (e.g. salbutamol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- History of hypersensitivity to lactose.
- Patients receiving β-blockers, anti-arrhythmics, polycyclic antidepressants and/or monoamine oxidase inhibitors within 4 weeks prior to the screening.
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- Asthma exacerbation (i.e. acute or sub-acute worsening in symptoms and lung function from the patient's usual status) or symptoms or signs of viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
- Use of oral or parenteral corticosteroids within 12 weeks prior to Screening visit (Visit 1)
- Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the patient's compliance with the study protocol or scheduled clinic visits.
- Female Subjects who are pregnant or breastfeeding.
- Women of child-bearing age that are not surgically incapable of pregnancy and are not willing to use an acceptable method of birth control.
- Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s).
- Unwillingness or inability to comply with the clinical trial procedures;
- Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- Who are legally incapacitated;
- Who are legally detained in an official institute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Multicenter, Parallel-group Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals, FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK, Placebo
- Keywords
- asthma, therapeutic equivalence, bioequivalence, fluticasone propionate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent PharmaceuticalsDrug
twice daily inhalation throughout the study
FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSKDrug
Also called FLOVENT
twice daily inhalation throughout the study
PlaceboDrug
twice daily inhalation throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals Receives: Drug: Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals |
| Reference Product | Active comparator | FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK Receives: Drug: FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dose FEV1
FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of a 28-days treatment after adjustment for baseline
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start9 Dec 2020
- Primary completion13 Aug 2021
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respirent Pharmaceuticals Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becro Ltd.
- Responsible party
- Sponsor
- Investigators
- Konstantinos Kostikas, Associate Professor, Principal investigator, University of Ioannina Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665895
- Sponsor's protocol ID
- BECRO/RESP/ANASSA-PD
- Acronym
- ANASSA-PD
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicenter, Parallel-group Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma
- ClinicalTrials.gov ID
- NCT04665895
- Acronym / sponsor ID
- ANASSA-PD / BECRO/RESP/ANASSA-PD
- Conditions
- Asthma
- Keywords
- asthma, therapeutic equivalence, bioequivalence, fluticasone propionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Respirent Pharmaceuticals Co Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Becro Ltd.
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 14 Dec 2020 (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.
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent PharmaceuticalsFluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals |
| Reference Product | Active comparator | Drug: FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSKFLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects (≥12 years of age) of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control.
- Patients diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP), at least 12 weeks months prior to screening (Visit 1).
- Pre-bronchodilator FEV1 of ≥45% and ≤85% of the predicted value (for age ≥18 years), or ≥65% and ≤90% predicted normal value (for ages 12 to 17 years) during the screening visit and on the first day of treatment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
- ≥12% and 200 mL reversibility of FEV1 within 30 minutes following 400 mcg salbutamol (4 puffs) inhalation (pMDI). This may be demonstrated at the Screening Visit or this test may be repeated on a different day if the patient fails the first attempt anytime in the period leading up to the day of randomization; If reversibility is not demonstrated up to the day of randomization then patients may be permitted to enter the study with historical evidence of reversibility that was performed within 2 years prior to Screening visit (Visit 1).
Key exclusion criteria (16 listed)
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year.
- Significant respiratory disease other than asthma (COPD, interstitial lung disease, chronic bronchitis, emphysema, etc.).
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Hypersensitivity to any sympathomimetic drug (e.g. salbutamol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- History of hypersensitivity to lactose.
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 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticalstwice daily inhalation throughout the study | Drug | Test Product |
| FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSKAlso: FLOVENTtwice daily inhalation throughout the study | Drug | Reference Product |
| Placebotwice daily inhalation throughout the study | Drug | Placebo |
Primary outcome
Pre-dose FEV1
Time frame: 28-days
FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of a 28-days treatment after adjustment for baseline
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 6 Apr 2023.
- 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.
Konstantinos Kostikas, Associate Professor principal investigator
University of Ioannina Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals and FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK in people with Asthma, run by Respirent Pharmaceuticals Co Ltd. at 1 site in Greece.
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 11 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: finished, as of the sponsor's last update on 6 Apr 2023. 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 Greece. 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 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 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?
Pre-dose FEV1 (time frame: 28-days). 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 6 Apr 2023.