AsthmaPhase 3NCT03756883
Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma
A Phase 3 study testing Fluticasone Propionate and Salmeterol Inhalation Powder in people with Asthma, run by Actavis Inc. at 1 site in United States.
Trial summary
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate and Salmeterol Inhalation Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 10 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female, ≥ 12 years and ≤ 75 years of age.
- Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations. For subjects who are considered minors in the state the study is being conducted (< 18 years in most states), the parent or legal guardian should sign the consent form and the child will be required to sign a subject "assent" form.
- Body mass index (BMI) between 18 kg/m2 and 39 kg/m2, inclusive, for subjects > 18 years old. For subjects 12 to 18 years old, BMI between 15 kg/m2 and 35 kg/m2, inclusive.
- Female subjects who are of non-childbearing potential must meet one of the following criteria:
- surgically sterile (e.g., bilateral oophorectomy, tubal ligation, hysterectomy or permanent sterilization procedures), with the procedure performed at least 3 months before initial dosing
- naturally postmenopausal (no menses) for at least 1 year before initial dosing and/or has a documented FSH level ≥ 40 mIU/mL at screening
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- pre-menarchal
- Females of childbearing potential must not be pregnant or lactating at Screening or Randomization as confirmed by a negative serum pregnancy test with a sensitivity of 25 mIU/mL of human chorionic gonadotropin at Screening, and a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL at all other visits. The subject may enter the placebo run-in period prior to receipt of test results at Screening, if not yet received from the clinical laboratory, but should be evaluated by the Investigator for continued participation once test results are received.
- Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control. Subjects on hormonal contraceptives must have been on the same hormonal contraceptive for at least one month before the Screening and continue throughout the duration of the study.
- Diagnosis of asthma (based on National Asthma Education and Prevention Program [NAEPP] guidelines) at least 12 weeks before Screening.
- Pre-bronchodilator FEV1 ≥ 40% and ≤ 85% of predicted at Screening and Randomization.
- Airway reversibility ≥ 15% of FEV1 within 30 minutes after receiving 4 puffs of albuterol inhalation (360 mcg, pressurized metered-dose inhaler) at Screening.
- Able to discontinue use of their asthma medications during the run-in period and for the remainder of the study.
- Able to replace current short-acting beta-agonists [SABAs] with the study supplied salbutamol/albuterol rescue inhaler for use as needed for the duration of the study. Subjects must be able to withhold all SABAs for at least 6 hours before lung function assessments on study visits.
- Able to continue on stable regimen of theophylline for the duration of the study and able to withhold theophylline as judged by the Investigator for the required time intervals before study visits. See Section 10.2.4 for required washouts.
- Able to discontinue oral corticosteroids, parenteral corticosteroids and oral SABAs for the time intervals before study visits as specified in Section 10.2.4.
- Able to perform valid and reproducible pulmonary function tests as per ATS American Thoracic Society including no evidence of spirometry effort-induced bronchoconstriction.
- Currently non-smoking (including vapor cigarettes), no use of any tobacco products within 1 year prior to Screening and has ≤ 10 pack-years smoking of historical use (i.e., one pack per day for 10 years).
- Ability to use the inhalation products correctly.
Who cannot join
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or asthma-related hospitalizations within one year before Screening or during the run-in period.
- Allergy or significant history of hypersensitivity, idiosyncratic reactions, or intolerance to any sympathomimetic drug (e.g., salmeterol or albuterol), or any inhaled, intranasal, or systemic corticosteroid therapy, or milk proteins.
- History of cystic fibrosis, bronchiectasis, or co-morbid respiratory or sinus diseases, including chronic obstructive pulmonary disease, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- Evidence of viral or bacterial upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, sinobronchitis, etc.), sinus infection, or middle ear infection within four weeks before Screening or during the run-in period.
- Current evidence or history of cardiovascular disorders, including uncontrolled hypertension, uncontrolled coronary artery disease, known aortic or cerebral aneurysm, myocardial infarction or stroke, and/or current coronary insufficiency that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- Cardiac arrhythmia or 12-lead ECG abnormalities that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations; or a QTc > 440 ms for males and > 460 ms for females using Fredericia formula.
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- Subjects receiving or who may require during the study non-potassium sparing diuretics or medications with the potential to affect the course of asthma or to interact with sympathomimetic amines within 30 days before Screening. Examples include but not limited to beta blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors.
- History of posterior subcapsular cataracts or glaucoma that, in the opinion of the Investigator, would compromise subject safety.
- Any clinically significant finding on physical exam or clinical labs that, in the opinion of the Investigator, would compromise subject's safety or data integrity.
- History or current evidence of significant renal, hepatic, cardiovascular (including ECG with evidence of ischemic heart disease, congestive heart failure, and cardiac dysrhythmia), neurologic, hematologic, endocrine, psychiatric dysfunction, or any other significant medical illness or disorder in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- History of convulsive disorders.
- History of hyperthyroidism.
- History of uncontrolled diabetes.
- History of paradoxical bronchospasm.
- Use of inhaled SABAs within 6 hours before Screening or use of rescue medication within 6 hours before Randomization.
- Use of oral SABAs within 12 hours before Screening.
- Use of oral or parenteral corticosteroids within one month before Screening.
- Use of muscarinic beta2-agonists (MABAs), ipratropium bromide, or ipratropium bromide with albuterol within 24 hours before Screening.
- Use of cromolyn sodium within 24 hours before Screening.
- Use of antihistamines (other than cetirizine, desloratadine, or diphenhydramine), including fexofenadine and loratadine, within 48 hours before Screening or Randomization.
- Use of cetirizine within 36 hours before Screening or Randomization.
- Use of desloratadine within 96 hours before Screening or Randomization.
- Use of diphenhydramine within 24 hours before Screening or Randomization.
- Use of inhaled long-acting beta2-agonists (LABAs) (e.g., salmeterol, formoterol) or combination products containing bronchodilators (e.g., Symbicort) within 24 hours before Screening.
- Use of tiotropium within one week before Screening.
- Exercise within 6 hours before Screening.
- Use of leukotriene modifiers within 24 hours before Screening.
- Any surgery within 6 months before Screening that, in the opinion of the Investigator, would compromise subject safety or integrity of the study data.
- Biological treatment for asthma, approved or investigational 6 months before Screening and throughout the study.
- Receipt of any drug as part of a research study within 30 days before Screening.
- Positive test results for drugs of abuse, alcohol or cotinine at Screening. Exceptions will be permitted for positive screens for opiates or stimulants provided there is a documented prescription for the patient with supporting medical history and diagnosis.
- Employees of the Investigator or research center or their immediate family members.
- Previous participation in this study.
- Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel-Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50 (Fluticasone Propionate/Salmeterol) Inhalation Powder, in Subjects With Asthma
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints
- Conditions
- Asthma
- Being tested
- Fluticasone Propionate and Salmeterol Inhalation Powder, Placebo Inhalation Powder
- 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 and Salmeterol Inhalation PowderDrug
100/50 mcg per actuation
Fluticasone Propionate and Salmeterol Inhalation PowderDrug
Also called ADVAIR DISKUS®
100/50 mcg per actuation
Placebo Inhalation PowderDrug
No active content
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg Receives: Drug: Fluticasone Propionate and Salmeterol Inhalation Powder |
| Reference | Active comparator | ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder Receives: Drug: Fluticasone Propionate and Salmeterol Inhalation Powder |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
Measured: 12 hours
Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.
Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
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 posted28 Nov 2018
- Study start3 Dec 2018
- Primary completion26 Oct 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756883
- Sponsor's protocol ID
- 71736001
- Status last verified
- Aug 2021
- First submitted
- 27 Nov 2018
- Last updated
- 24 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel-Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50 (Fluticasone Propionate/Salmeterol) Inhalation Powder, in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT03756883
- Acronym / sponsor ID
- 71736001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Fluticasone Propionate and Salmeterol Inhalation PowderFluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg |
| Reference | Active comparator | Drug: Fluticasone Propionate and Salmeterol Inhalation PowderADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder |
| Placebo | Placebo comparator | Drug: Placebo Inhalation PowderPlacebo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Male or non-pregnant, non-lactating female, ≥ 12 years and ≤ 75 years of age.
- Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations. For subjects who are considered minors in the state the study is being conducted (< 18 years in most states), the parent or legal guardian should sign the consent form and the child will be required to sign a subject "assent" form.
- Body mass index (BMI) between 18 kg/m2 and 39 kg/m2, inclusive, for subjects > 18 years old. For subjects 12 to 18 years old, BMI between 15 kg/m2 and 35 kg/m2, inclusive.
- Female subjects who are of non-childbearing potential must meet one of the following criteria:
- Females of childbearing potential must not be pregnant or lactating at Screening or Randomization as confirmed by a negative serum pregnancy test with a sensitivity of 25 mIU/mL of human chorionic gonadotropin at Screening, and a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL at all other visits. The subject may enter the placebo run-in period prior to receipt of test results at Screening, if not yet received from the clinical laboratory, but should be evaluated by the Investigator for continued participation once test results are received.
Key exclusion criteria (34 listed)
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or asthma-related hospitalizations within one year before Screening or during the run-in period.
- Allergy or significant history of hypersensitivity, idiosyncratic reactions, or intolerance to any sympathomimetic drug (e.g., salmeterol or albuterol), or any inhaled, intranasal, or systemic corticosteroid therapy, or milk proteins.
- History of cystic fibrosis, bronchiectasis, or co-morbid respiratory or sinus diseases, including chronic obstructive pulmonary disease, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
- Evidence of viral or bacterial upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, sinobronchitis, etc.), sinus infection, or middle ear infection within four weeks before Screening or during the run-in period.
- Current evidence or history of cardiovascular disorders, including uncontrolled hypertension, uncontrolled coronary artery disease, known aortic or cerebral aneurysm, myocardial infarction or stroke, and/or current coronary insufficiency that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
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 and Salmeterol Inhalation Powder100/50 mcg per actuation | Drug | Test |
| Fluticasone Propionate and Salmeterol Inhalation PowderAlso: ADVAIR DISKUS®100/50 mcg per actuation | Drug | Reference |
| Placebo Inhalation PowderNo active content | Drug | Placebo |
Primary outcome
Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment
Time frame: 12 hours
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.
Time frame: 28 days
Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No participant data will be shared.
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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 3 study testing Fluticasone Propionate and Salmeterol Inhalation Powder in people with Asthma, run by Actavis Inc. at 1 site in United States.
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 19 inclusion and 34 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 24 Sep 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 States. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment (time frame: 12 hours). The study lists 2 primary outcomes in all. 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 24 Sep 2021.