HealthyPhase 1NCT02232087
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
A Phase 1 study testing Salmeterol and fluticasone propionate in people with Healthy, run by Kindeva Drug Delivery at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salmeterol and fluticasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Dec 2014
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteer
- Willing and able to give informed consent
- Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- Male and female subjects aged 18 to 55 years (inclusive)
- Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
Who cannot join
- Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- History of drug or alcohol abuse within the past 2 years
- Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
Show all 12Show fewer
- Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
- Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- If female, nursing, lactating or pregnant
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Surgery scheduled during the study or within 3 weeks after last dose
- History of familial long QT syndrome or history of sudden death in family members aged < 30 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd
Ruddington, Nottingham, NG11 6JS
About this study
Official title: Phase I Single Blind, Randomised, Cross-over Pharmacodynamic Dose Response Study in Healthy Volunteers of Two Pressurized Metered Dose Inhalers (pMDIs) That Deliver Salmeterol and Fluticasone Propionate
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
Read the detailed description
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
- Conditions
- Healthy
- Being tested
- Salmeterol, fluticasone propionate
- Keywords
- long-acting beta agonist (LABA), corticosteroid, pMDI, inhaler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalmeterolDrug
Also called Sirdupla, Seretide Evohaler
A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
fluticasone propionateDrug
Also called Sirdupla, Seretide Evohaler
A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
| Study group | Role | What they receive |
|---|---|---|
| test product A | Experimental | salmeterol and fluticasone propionate, 2 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
| reference product D | Active comparator | salmeterol and fluticasone propionate, 2 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
| test product B | Experimental | salmeterol and fluticasone propionate, 6 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
| reference product E | Active comparator | salmeterol and fluticasone propionate, 6 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
| test product C | Experimental | salmeterol and fluticasone propionate, 12 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
| reference product F | Active comparator | salmeterol and fluticasone propionate, 12 puffs Receives: Drug: Salmeterol; Drug: fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Potency Max Heart Rate
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Measured: Baseline, up to 6 hrs
Relative Potency QTcB Interval
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
Measured: Baseline up to 6 hrs
Secondary outcomes (4)
Max Heart Rate
max heart rate at the 2, 6, or 12 inhalations dose, assessed at multiple times over 6 hours
Measured: Baseline through 6 hours
Plasma Potassium Level
maximum plasma levels of potassium at 2, 6 or 12 inhalations dose inhalations dose, assessed a multiple times over 6 hours.
Measured: baseline through 6 hours
Max Plasma Glucose Level
maximum levels of glucose at the 2, 6 or 12 inhalations dose, assessed at multiple times over 6 hours.
Measured: baseline through 6 hours
Max QTcB
For each dose, the 95% CIs for the mean difference for the test product versus the reference product were calculated.
Measured: Baseline through 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionDec 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kindeva Drug Delivery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pui Leung, MD, Principal investigator, Quotient Clinical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232087
- Sponsor's protocol ID
- DDSD-1030-SAFL
- Status last verified
- Oct 2020
- First submitted
- 2 Sep 2014
- Last updated
- 15 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Harrison LI, Sessions V, Wiggenhorn CJ, Chalmers D, Leung P, Efthimiou J. Comparison of systemic pharmacodynamic effects of two combination pressurized metered dose inhalers that deliver salmeterol and fluticasone propionate. Br J Clin Pharmacol. 2017 Nov;83(11):2377-2385. doi: 10.1111/bcp.13349. Epub 2017 Aug 1.
PubMed 28626983
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single Blind, Randomised, Cross-over Pharmacodynamic Dose Response Study in Healthy Volunteers of Two Pressurized Metered Dose Inhalers (pMDIs) That Deliver Salmeterol and Fluticasone Propionate
- ClinicalTrials.gov ID
- NCT02232087
- Acronym / sponsor ID
- DDSD-1030-SAFL
- Conditions
- Healthy
- Keywords
- long-acting beta agonist (LABA), corticosteroid, pMDI, inhaler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kindeva Drug DeliveryIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Posted 2 Nov 2020
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 test the body's response to several doses of two different inhalation products in healthy volunteers.
Detailed description
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| test product A | Experimental | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 2 puffs |
| reference product D | Active comparator | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 2 puffs |
| test product B | Experimental | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 6 puffs |
| reference product E | Active comparator | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 6 puffs |
| test product C | Experimental | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 12 puffs |
| reference product F | Active comparator | Drug: Salmeterol, Drug: fluticasone propionatesalmeterol and fluticasone propionate, 12 puffs |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Volunteer
- Willing and able to give informed consent
- Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- Male and female subjects aged 18 to 55 years (inclusive)
- Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
Key exclusion criteria (12 listed)
- Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- History of drug or alcohol abuse within the past 2 years
- Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- Donation or loss of greater than 400 mL of blood within the previous 3 months
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 |
|---|---|---|
| SalmeterolAlso: Sirdupla, Seretide EvohalerA, D 2 puffs; B, E 6 puffs; C, F 12 puffs | Drug | reference product D, reference product E, reference product F, test product A, test product B, test product C |
| fluticasone propionateAlso: Sirdupla, Seretide EvohalerA, D 2 puffs; B, E 6 puffs; C, F 12 puffs | Drug | reference product D, reference product E, reference product F, test product A, test product B, test product C |
Primary outcome
Relative Potency Max Heart Rate
Time frame: Baseline, up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Relative Potency QTcB Interval
Time frame: Baseline up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
4 secondary outcomes
Max Heart Rate
Time frame: Baseline through 6 hours
Plasma Potassium Level
Time frame: baseline through 6 hours
Max Plasma Glucose Level
Time frame: baseline through 6 hours
Max QTcB
Time frame: Baseline through 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28626983Harrison LI, Sessions V, Wiggenhorn CJ, Chalmers D, Leung P, Efthimiou J. Comparison of systemic pharmacodynamic effects of two combination pressurized metered dose inhalers that deliver salmeterol and fluticasone propionate. Br J Clin Pharmacol. 2017 Nov;83(11):2377-2385. doi: 10.1111/bcp.13349. Epub 2017 Aug 1.
- 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.
Pui Leung, MD principal investigator
Quotient Clinical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Salmeterol and fluticasone propionate in people with Healthy, run by Kindeva Drug Delivery 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 5 inclusion and 12 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 15 Jun 2022. 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. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). 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?
Relative Potency Max Heart Rate (time frame: Baseline, up to 6 hrs). 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 NCT02232087, 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 15 Jun 2022.