AsthmaPhase 1NCT02218762
A Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the ROTAHALER® Inhaler Relative to the DISKUS® Inhaler
A Phase 1 study testing Fluticasone Propionate/Salmeterol Xinafoate DISKUS and Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS in people with Asthma, run by GlaxoSmithKline.
Trial summary
The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg) twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and licensed therapy for the treatment of asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate/Salmeterol Xinafoate DISKUS and Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a known physician diagnosis of asthma with a best Forced Expiratory Volume in 1 Second (FEV1) of >70% of the predicted normal value at the Screening visit. Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Subjects must abstain from short acting beta-2 agonists (SABA) use for 6 hours prior to the Screening visit.
- During the screening visit, subjects must either demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >=12.0% over baseline and an absolute change of >=200 millilitres (mL) within 60 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) or in the absence of reversibility have documented evidence of a physician diagnosed asthma for at least 6 months
- Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 18 - 35.0 kilogram/square meter (kg/m^2) (inclusive).
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per/millilitre (MIU/mL) and estradiol <40 picogram/millilitre (pg/mL) (<147 picomoles per liter [pmol/L]) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.; Child-bearing potential with negative pregnancy test as determined by serum or human chorionic gonadotropin (hCG) test at screening or urine hCG test prior to dosing AND ; Agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.; OR has only same-sex partners, when this is her preferred and usual lifestyle.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
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- Subjects who are current non-smokers and who have a pack history of <=10 pack years. A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco). [number of pack years = (number of cigarettes per day / 20) x number of years smoked].
- Alanine transaminase (ALT), alkaline phosphatase and bilirubin <= 1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiogram (ECGs) obtained over a brief recording period: QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (msec); or QTcF <480 msec in subjects with Bundle Branch Block.
- Asthma therapy: Subjects must have been on their current therapy for at least eight weeks and a stable dose for four weeks prior to the screening visit:
- Subjects on fluticasone propionate/salmeterol combination 100/50 microgram (mcg) treatment via a DISKUS inhaler prior to the study will be allowed to remain on their treatment regimen until randomization provided all other eligibility criteria are met.;
- Subjects on treatment with fluticasone propionate/salmeterol combination 125/25 mcg via a metered dose inhaler will be required to switch to fluticasone propionate/salmeterol combination 100/50 mcg via the GlaxoSmithkline (GSK)-provided DISKUS inhaler for between 14 and 28 days prior to randomization;
- Subjects on low dose inhaled corticosteriod (ICS) monotherapy (up to a total daily dose of fluticasone propionate 250 total daily dose mcg or other ICS equivalent e.g. budesonide up to 400 mcg total daily dose) will switch to fluticasone propionate/salmeterol combination 100/50 mcg via the GSK-provided DISKUS inhaler for between 14 and 28 days prior to randomization;
- Subjects on medium dose ICS monotherapy ( greater than 250 and up to 500 mcg of fluticasone propionate total daily dose or other ICS equivalent e.g. budesonide greater than 400 mcg and up to 800 mcg total daily dose) will switch to fluticasone propionate/salmeterol combination 100/50 mcg twice daily via the GSK-provided DISKUS inhaler for 28 days prior to randomization;
- Subjects on low dose Symbicort (any doses that are no greater than 400/12 mcg total daily dose) will be switched to fluticasone propionate/salmeterol combination 100/50 mcg via the GSK-provided DISKUS inhaler for between 14 and 28 days prior to randomization.
Who cannot join
- Criteria Based Upon Medical Histories
- Any clinically relevant medical condition or abnormality identified during the screening medical assessment and procedures, physical examination, or laboratory assessments (including clinical chemistry and haematology), which in the opinion of the Investigator and/or GSK Medical Monitor is likely to affect the safety of the subject and/or interfere with the study procedures and outcomes.
- Acute exacerbation of asthma in the last 6 months prior to the Screening visit.
- Subjects on treatment with fluticasone propionate either as monotherapy or in combination at a total daily dose higher than 500 mcg or budesonide monotherapy or in combination at a total daily dose higher than 800 mcg or beclomethasone (CFC) at a total daily dose higher than 1000 mcg or beclomethasone (HFA) at a total daily dose higher than 400mcg are excluded from the study
- Subjects with other significant pulmonary diseases (pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma).
- Use of oral/injectable/depot corticosteroid for any indication within 3 months prior to the Screening visit.
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- Use of any anti immunoglobulin E (Anti-IgE) (e.g. Xolair) in any period prior to screening.
- Use of intra-nasal steroids (INS). To be eligible for the study, patients on INS therapy will be required to switch to non-INS therapy at screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: For Australian sites: An average weekly intake of >21 units for males or >14 units for females. One unit (= standard drink) is equivalent to 10 g of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%); For South African sites: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 330 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- A known or suspected history of drug abuse within 12 months of the Screening visit.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of sensitivity to salbutamol or any of the study medications, or components thereof (including severe milk protein allergy) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Criteria Based Upon Diagnostic Assessments
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug screen.
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- Subjects with known abnormal levels of serum cortisol
- A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis prior to randomisation
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Lactating females.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Grapefruit or grapefruit juice containing products are excluded from 2 weeks prior to randomisation until collection of the final blood sample at treatment period 4.
- Drugs that inhibit the cytochrome P450 isoform, 3A4 (CYP3A4), are excluded from 2 weeks prior to randomisation until collection of the final blood sample at treatment period 4. CYP3A4 inhibitors include cimetidine, clarithromycin, erythromycin, ciprofloxacin, ritonavir, ketoconazole, and azole antifungals.
- Use of prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication, which in the opinion of the Principal Investigator, may interfere with study outcome. Specifically, calcium and vitamin D supplements and bisphosphonates are not allowed throughout the study.
- Subjects, who, in the opinion of the Investigator, are not able to comply with the protocol requirements.
About this study
Official title: A Randomised, Two Treatment, Four-Way Cross-Over (Replicate Design), Two Sequence, Repeat Dose Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the Low Airflow Resistance Fluticasone Propionate/Salmeterol (100/50 mcg) ROTAHALER Inhaler Relative to Fluticasone Propionate/Salmeterol (100/50 mcg) Delivered Via the DISKUS Inhaler
The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg) twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment, four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58 subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject will be allocated to one of two treatment sequences and will participate in four treatment periods, receiving each of the treatments twice.
DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of companies.
- Conditions
- Asthma
- Being tested
- Fluticasone Propionate/Salmeterol Xinafoate DISKUS, Placebo to Match DISKUS, Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS, Placebo to Match ROTACAPS
- Keywords
- Fluticasone propionate/salmeterol in a capsule-based inhaler, replicated cross-over design, Respiratory, asthma, safety, pharmacokinetics, Fluticasone propionate/salmeterol, pharmacodynamics, Fluticasone propionate/salmeterol in a multi-dose dry powder inhaler
- 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/Salmeterol Xinafoate DISKUSDrug
A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of powder comprising of a blend of fluticasone propionate (micronized)(100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One blister to be administered twice daily via DISKUS inhaler
Placebo to Match DISKUSDrug
A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of lactose and powder comprising of excipient(s). One blister to be administered twice daily via DISKUS inhaler
Fluticasone Propionate/Salmeterol Xinafoate ROTACAPSDrug
A capsule containing a small quantity of powder comprising of a blend of fluticasone propionate (micronized) (100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler
Placebo to Match ROTACAPSDrug
A capsule containing a small quantity of lactose and powder comprising of excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Subjects will receive FSC 100/50 mcg delivered via the Ddpi (Treatment A) and FSC 100/50 mcg delivered via the Rdpi (Treatment B) in the sequence of A-B-B-A in four treatment periods of 10 days each. Subjects will receive both active treatment and matching placebo at the same time from two separate devices twice daily. There will be no wash-out between treatment periods Receives: Drug: Fluticasone Propionate/Salmeterol Xinafoate DISKUS; Drug: Placebo to Match DISKUS; Drug: Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS; Drug: Placebo to Match ROTACAPS |
| Sequence 2 | Experimental | Subjects will receive FSC 100/50 mcg delivered via the Ddpi (Treatment A) and FSC 100/50 mcg delivered via the Rdpi (Treatment B) in the sequence of B-A-A-B in four treatment periods of 10 days each. Subjects will receive both active treatment and matching placebo at the same time from two separate devices twice daily. There will be no wash-out between treatment periods Receives: Drug: Fluticasone Propionate/Salmeterol Xinafoate DISKUS; Drug: Placebo to Match DISKUS; Drug: Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS; Drug: Placebo to Match ROTACAPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluticasone propionate (FP) area under the concentration-time curve over the dosing interval (AUCtau)
FP AUCtau will be determined from the plasma FP concentration-time data
Measured: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
Salmeterol maximum observed concentration (Cmax)
Salmeterol Cmax will be determined from the plasma salmeterol concentration-time data
Measured: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
Secondary outcomes (10)
Salmeterol AUCtau
Salmeterol AUCtau will be determined from the plasma FP concentration-time data
Measured: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
FP Cmax
FP Cmax will be determined from the plasma FP concentration-time data
Measured: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
FP and salmeterol time to Cmax (Tmax)
FP and salmeterol Tmax will be determined from the plasma FP concentration-time data
Measured: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
Weighted mean serum cortisol over 12 hours on the last day of each treatment period (Day 10)
Blood sampling for measurement of serum cortisol will be performed on the last day of each treatment period (Day 10) at pre-morning dose and at 30 min, 1,2,4,8,10 and 12 hours post- morning dose. Weighted mean concentration from 0 to 12 hours will be derived from the serum cortisol concentration data
Measured: Day 10 of each treatment period
Serum cortisol minimum observed concentration (Cmin)
Blood sampling for measurement of serum cortisol will be performed on the last day of each treatment period (Day 10) at pre-morning dose and at 30 min, 1,2,4,8,10 and 12 hours post- morning dose. Cmin will be derived from the serum cortisol concentration data
Measured: Day 10 of each treatment period
Heart rate (HR) measurements
Measured: Up to 10 weeks
Blood pressure (BP) measurements
Systolic and diastolic blood pressure will be measured
Measured: Up to 10 weeks
Potassium and Glucose measurements
Blood sampling for measurement of potassium and glucose will be performed on Day 1 Treatment Period 1 (pre-dose) and on Day 10 of each treatment period (pre-morning dose and at 30, 60 minutes, 2 and 4 hours post the morning dose)
Measured: Up to 10 weeks
Number of subjects with adverse events
An adverse event is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Up to 12 weeks
Clinical laboratory safety assessments
Haematology, clinical chemistry, and urinalysis parameters
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: It was decided that data from this study are no longer required and therefore it is not necessary to expose patients to the study medication
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218762
- Sponsor's protocol ID
- 201461
- Status last verified
- Feb 2015
- First submitted
- 14 Aug 2014
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Two Treatment, Four-Way Cross-Over (Replicate Design), Two Sequence, Repeat Dose Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the Low Airflow Resistance Fluticasone Propionate/Salmeterol (100/50 mcg) ROTAHALER Inhaler Relative to Fluticasone Propionate/Salmeterol (100/50 mcg) Delivered Via the DISKUS Inhaler
- ClinicalTrials.gov ID
- NCT02218762
- Acronym / sponsor ID
- 201461
- Conditions
- Asthma
- Keywords
- Fluticasone propionate/salmeterol in a capsule-based inhaler, replicated cross-over design, Respiratory, asthma, safety, pharmacokinetics, Fluticasone propionate/salmeterol, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided that data from this study are no longer required and therefore it is not necessary to expose patients to the study medication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Aug 2014 (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 Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg) twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment, four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58 subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject will be allocated to one of two treatment sequences and will participate in four treatment periods, receiving each of the treatments twice.
DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of companies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Fluticasone Propionate/Salmeterol Xinafoate DISKUS, Drug: Placebo to Match DISKUS, Drug: Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS, Drug: Placebo to Match ROTACAPSSubjects will receive FSC 100/50 mcg delivered via the Ddpi (Treatment A) and FSC 100/50 mcg delivered via the Rdpi (Treatment B) in the sequence of A-B-B-A in four treatment periods of 10 days each. Subjects will receive both active treatment and matching placebo at the same time from two separate devices twice daily. There will be no wash-out between treatment periods |
| Sequence 2 | Experimental | Drug: Fluticasone Propionate/Salmeterol Xinafoate DISKUS, Drug: Placebo to Match DISKUS, Drug: Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS, Drug: Placebo to Match ROTACAPSSubjects will receive FSC 100/50 mcg delivered via the Ddpi (Treatment A) and FSC 100/50 mcg delivered via the Rdpi (Treatment B) in the sequence of B-A-A-B in four treatment periods of 10 days each. Subjects will receive both active treatment and matching placebo at the same time from two separate devices twice daily. There will be no wash-out between treatment periods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects with a known physician diagnosis of asthma with a best Forced Expiratory Volume in 1 Second (FEV1) of >70% of the predicted normal value at the Screening visit. Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Subjects must abstain from short acting beta-2 agonists (SABA) use for 6 hours prior to the Screening visit.
- During the screening visit, subjects must either demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >=12.0% over baseline and an absolute change of >=200 millilitres (mL) within 60 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) or in the absence of reversibility have documented evidence of a physician diagnosed asthma for at least 6 months
- Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 18 - 35.0 kilogram/square meter (kg/m^2) (inclusive).
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per/millilitre (MIU/mL) and estradiol <40 picogram/millilitre (pg/mL) (<147 picomoles per liter [pmol/L]) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.; Child-bearing potential with negative pregnancy test as determined by serum or human chorionic gonadotropin (hCG) test at screening or urine hCG test prior to dosing AND ; Agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.; OR has only same-sex partners, when this is her preferred and usual lifestyle.
Key exclusion criteria (27 listed)
- Criteria Based Upon Medical Histories
- Any clinically relevant medical condition or abnormality identified during the screening medical assessment and procedures, physical examination, or laboratory assessments (including clinical chemistry and haematology), which in the opinion of the Investigator and/or GSK Medical Monitor is likely to affect the safety of the subject and/or interfere with the study procedures and outcomes.
- Acute exacerbation of asthma in the last 6 months prior to the Screening visit.
- Subjects on treatment with fluticasone propionate either as monotherapy or in combination at a total daily dose higher than 500 mcg or budesonide monotherapy or in combination at a total daily dose higher than 800 mcg or beclomethasone (CFC) at a total daily dose higher than 1000 mcg or beclomethasone (HFA) at a total daily dose higher than 400mcg are excluded from the study
- Subjects with other significant pulmonary diseases (pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma).
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/Salmeterol Xinafoate DISKUSA blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of powder comprising of a blend of fluticasone propionate (micronized)(100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One blister to be administered twice daily via DISKUS inhaler | Drug | Sequence 1, Sequence 2 |
| Placebo to Match DISKUSA blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of lactose and powder comprising of excipient(s). One blister to be administered twice daily via DISKUS inhaler | Drug | Sequence 1, Sequence 2 |
| Fluticasone Propionate/Salmeterol Xinafoate ROTACAPSA capsule containing a small quantity of powder comprising of a blend of fluticasone propionate (micronized) (100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler | Drug | Sequence 1, Sequence 2 |
| Placebo to Match ROTACAPSA capsule containing a small quantity of lactose and powder comprising of excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler | Drug | Sequence 1, Sequence 2 |
Primary outcome
Fluticasone propionate (FP) area under the concentration-time curve over the dosing interval (AUCtau)
Time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
FP AUCtau will be determined from the plasma FP concentration-time data
Salmeterol maximum observed concentration (Cmax)
Time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
Salmeterol Cmax will be determined from the plasma salmeterol concentration-time data
10 secondary outcomes
Salmeterol AUCtau
Time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
FP Cmax
Time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
FP and salmeterol time to Cmax (Tmax)
Time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)
Weighted mean serum cortisol over 12 hours on the last day of each treatment period (Day 10)
Time frame: Day 10 of each treatment period
Serum cortisol minimum observed concentration (Cmin)
Time frame: Day 10 of each treatment period
Heart rate (HR) measurements
Time frame: Up to 10 weeks
Blood pressure (BP) measurements
Time frame: Up to 10 weeks
Potassium and Glucose measurements
Time frame: Up to 10 weeks
Number of subjects with adverse events
Time frame: Up to 12 weeks
Clinical laboratory safety assessments
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluticasone Propionate/Salmeterol Xinafoate DISKUS and Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS in people with Asthma, run by GlaxoSmithKline.
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 15 inclusion and 27 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: withdrawn, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Fluticasone propionate (FP) area under the concentration-time curve over the dosing interval (AUCtau) (time frame: Day 10 of each treatment period (pre-morning dose and at 5, 10, 30 minutes and 1, 2, 4, 8, 10 and 12 hours post- morning dose)). 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 11 Feb 2015.