AzTrials
AzTrials

AsthmaPhase 1NCT02437604

Study to Determine the Pharmacokinetics and Tolerability of Fluticasone Propionate MDPI and Fluticasone Propionate/Salmeterol MDPI Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older

A Phase 1 study testing Treatment A: Fp MDPI, Treatment B: FS MDPI and Treatment C Flovent in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Each patient will participate in the study for approximately 7 weeks. Participation will include a screening period of up to 21 days and 4 treatment periods; each consisting of a 3-day/2-night inpatient period. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Treatment A: Fp MDPI, Treatment B: FS MDPI and Treatment C Flovent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
3 sitesUnited States
Study dates
May 2015to Sep 2015
Phase
Phase 1
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

None listed.

Who cannot join

  • The patient has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
  • The patient has participated as a randomized patient in any investigational drug study within 30 days (starting from the final follow-up visit of that study) preceding the SV or plans to participate in another investigational drug study at any time during this study.
  • The patient has previously participated in an Fp MDPI or FS MDPI study. Participation is defined as randomization to treatment.
  • The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug (ie, lactose).
  • The patient has been treated with any known cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV or plans to be treated with any CYP3A4 inhibitor during the study.The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
Show all 16Show fewer
  • The patient has either lost or donated ≥500 mL of whole blood within the 60 days before the first dose of study drug or the patient has received or donated plasma, white blood cells, or platelets within the 14 days before the first dose of study drug. Patients that have plans to donate blood or blood products during the study or within the 90 days after completion of the study are also excluded.
  • The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
  • The patient has a culture-documented or suspected bacterial or viral upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI),
  • The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
  • The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
  • The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. Note: Azole antifungals are prohibited.
  • The patient is either an employee or an immediate relative of an employee of the investigational center.
  • A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
  • The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
  • Other criteria may apply, please contact the investigator for more information.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Teva Investigational Site 13177

    Edmond, Oklahoma

  • Teva Investigational Site 13178

    Raleigh, North Carolina

  • Teva Investigational Site 13179

    San Antonio, Texas

Other trials in United States

About this study

Official title: An Open-Label, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of High Strength Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older

Each patient will participate in the study for approximately 7 weeks. Participation will include a screening period of up to 21 days and 4 treatment periods; each consisting of a 3-day/2-night inpatient period.

Conditions
Asthma
Being tested
Treatment A: Fp MDPI, Treatment B: FS MDPI, Treatment C Flovent, Treatment D: Advair
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment A: Fp MDPIDrug

    Also called fluticasone propionate

    Fp MDPI 200 mcg, 1 inhalation

  • Treatment B: FS MDPIDrug

    Also called fluticasone propionate/salmeterol

    FS MDPI 200/12.5 mcg, 1 inhalation

  • Treatment C FloventDrug

    Also called fluticasone propionate

    FLOVENT DISKUS 250 mcg, 2 inhalations

  • Treatment D: AdvairDrug

    Also called fluticasone propionate/salmeterol

    ADVAIR DISKUS 500/50 mcg, 1 inhalation

Study groups in NCT02437604
Study groupRoleWhat they receive
Treatment AExperimentalFp MDPI 200 mcg, 1 inhalation
Receives: Drug: Treatment A: Fp MDPI
Treatment BExperimentalFS MDPI 200/12.5 mcg, 1 inhalation
Receives: Drug: Treatment B: FS MDPI
Treatment CActive comparatorfluticasone propionate (FLOVENT DISKUS) 250 mcg, 2 inhalations
Receives: Drug: Treatment C Flovent
Treatment DActive comparatorfluticasone propionate/salmeterol (ADVAIR DISKUS) 500/50 mcg, 1 inhalation
Receives: Drug: Treatment D: Advair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-t Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours After administration

  2. Cmax Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours After administration

Secondary outcomes (7)

  1. AUC0-∞ Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  2. AUC%extrap Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  3. tmax Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  4. t½ Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  5. λz Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  6. CL/F Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

  7. Vz/F Plasma drug concentration

    Measured: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437604
Sponsor's protocol ID
FSS-AS-10042
Status last verified
Nov 2021
First submitted
5 May 2015
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
No

Publications

  • Nugent C, Yiu G, Song S, Caracta C. The pharmacokinetics, safety, and tolerability of single, high-strength doses of fluticasone propionate and fluticasone propionate/salmeterol delivered via a novel multidose dry powder inhaler in adolescents and adults with persistent asthma. J Asthma. 2018 Aug;55(8):898-906. doi: 10.1080/02770903.2017.1373392. Epub 2017 Oct 30.

    PubMed 28933971

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A: Fp MDPI, Treatment B: FS MDPI and Treatment C Flovent in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites 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 0 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AUC0-t Plasma drug concentration (time frame: 0.08, 0.25, 0.5, 0.75, 1, 2, 4, 8, 12, 16, 24, 30, and 36 hours After administration). 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?

On the ClinicalTrials.gov record for NCT02437604, 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 9 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in