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Allergic RhinitisPhase 1NCT01190852

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays

A Phase 1 study testing Azelastine, Fluticasone, Azelastine mono and Azelastine in people with Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 1 site in Germany.

Completed

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

Official record
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Trial summary

The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Allergic Rhinitis
What is being tested?
Azelastine, Fluticasone, Azelastine mono and Azelastine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
Aug 2010to Oct 2010
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female healthy subjects of any Ethnic origin, age from 18 to 45 years.
  • Body mass index (BMI) from 18.5 to 30.0 kg/m2.
  • Use of adequate double contraception by female with childbearing potential (i.e. women of child bearing potential using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs) or surgically sterile (documented complete hysterectomy or bi-tubal ligations; partial hysterectomy is not sufficient or vasectomised partner). It must be ensured that the male partner uses a condom during intercourse (if not surgically sterilized).
  • Use of adequate double contraception by male, who is a sexually active man and has not been surgically sterilized, must consent that he uses a condom during intercourse and ensures that his female partner practices adequate contraception (a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs) or surgically sterile (documented complete hysterectomy or bi-tubal ligations; partial hysterectomy is not sufficient).
  • Written informed consent.
  • Able to demonstrate correct nasal spray application technique at screening.

Who cannot join

  • History of allergic reaction or sensitivity to azelastine hydrochloride, fluticasone propionate or one of the excipients (e.g. benzalkoniumchloride, phenyl-ethyl alcohol).
  • Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease at screening.
  • Positive ß-HCG pregnancy test, or established pregnancy, breast-feeding or planned pregnancy during the study.
  • Lack of suitability for the study:
  • History of haemophilia or coagulation disease.
  • Significant history of orthostatic hypotension, fainting or blackouts.
Show all 29Show fewer
  • Existence of any surgical or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of study drug.
  • Chronic or clinically relevant acute infections (e.g. of the respiratory tract including sinusitis and rhinitis), acute rhinorrhoea or febrile disease the week before randomisation.
  • Clinical chemical, haematological or any other laboratory parameters clinically relevant outside the reference range (e.g. elevated liver enzymes, renal laboratory parameters, and coagulation abnormalities such as abnormalities of platelet count, prothrombin time, or activated partial thromboplastin time).
  • Positive results in HIV, HCV and HBsAg tests.
  • ECG abnormalities of clinical relevance, in particular abnormal prolongations of QT/QTc- or PQ-interval (i.e. QTc according to Fridericia ≥ 450 ms, PQ ≥ 220 ms).
  • Resting heart rate in the awake subject below 45 BPM or above 90 BPM, systolic blood pressure below 100 mmHg or above 145 mmHg, diastolic blood pressure above 95 mmHg.
  • Regular therapy with corticosteroids (e.g. fluticasone propionate) or antihistamines (e.g. azelastine hydrochloride).
  • Any concurrent medication or any medication within 2 weeks preceding the start of the study (single intake/use of drugs may be accepted, if judged by the investigator to have no clinical relevance and no influence on study outcome).
  • Exposure to any cytochrome P450 3A4 inhibiting or inducing drug (e.g. ritonavir, ketoconazole, itraconazole, erythromycin, rifampicin, St. John's wort (Hypericum perforatum) etc.) diets (charcoal grilled meat, brussels sprouts, broccoli) or beverages (e.g. grapefruit juice) within 14 days prior to study enrolment, or anticipated consumption of such products during that period or at any time throughout the study.
  • History of any nasal surgery or known clinically relevant abnormalities, such as rhinitis medicamentosa, polyposis, septum deviation with clinical symptoms, or nasal structural abnormalities.
  • Known perennial airway allergies. Known seasonal airway allergies which are clinically relevant acute within the last six weeks prior to the start of the study or might become acute during the study period.
  • History of malignancy within the past five years.
  • Blood donation within the last 2 months prior to the start of the study.
  • Present or history of drug or alcohol abuse within the last three years. Regular daily consumption of more than half a litre of usual beer or 0.25 L of wine per day or the equivalent quantity of approximately 30 g of alcohol in another form.
  • Current smoker or smoking during the last year.
  • Exposure to an investigational medicinal product within the last 3 months.
  • Subject reports a regular xanthine consumption of > 5 cups of coffee or black tea per day (or equivalent xanthine consumption of ≥ 500 mg xanthine per day using other products).
  • Subject is vegetarian or reports other strict dietary habits which would preclude the subject's acceptance of standardized meals
  • Lack of ability or willingness to give informed consent.
  • Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
  • Lack of willingness or inability to co-operate adequately.
  • Anticipated non-availability for study visits/procedures.
  • Vulnerable subjects (such as persons kept in detention).

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • ClinPharmCologne

    Cologne, North Rhine-Westphalia, 51063

Other trials in Germany

About this study

Official title: Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays Single-centre, Randomised, Open-label, Three-period, Six-sequence Cross-over Trial (William's Design)

The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF).

The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Read the detailed description

This study will enrol healthy subjects. It is considered that study results are more discriminative in healthy subjects than in rhinitis patients as there are no interferences by varying rhinitis symptoms and respective differences in the status of the nasal mucosa regarding the 3 study periods.

The time schedule for plasma sampling (pre-dose and 15, 30 min, 1, 1½, 2, 2½, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h p.a.; time refer to the end of the second spray into the second nostril of each administration) is derived from previous bioavailability study on the marketed product Astelin® Nasal Spray assuming a mean tmax of 2 to 3 h p.a. and a mean t1/2 of 22 h [L7]. Sampling times are expected to cover an AUC0-tlast above 80% of the total AUC of azelastine hydrochloride (bioanalytical detection method with a LLOQ of 2 pg/mL).

Being tested
Azelastine, Fluticasone, Azelastine mono, Azelastine
Medical subject headings
Rhinitis, Allergic

What participants receive

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

  • Azelastine, FluticasoneDrug

    Also called MP29-02

    TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray

  • Azelastine monoDrug

    Also called Azelastine

    REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)

  • AzelastineDrug

    Also called Astelin®

    COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)

Study groups in NCT01190852
Study groupRoleWhat they receive
Azelastine, FluticasoneExperimentalTEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray
Receives: Drug: Azelastine, Fluticasone
Azelastine monoActive comparatorREF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)
Receives: Drug: Azelastine mono
AzelastineActive comparatorCOMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)
Receives: Drug: Azelastine

What is being measured

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

  1. Effect of fluticasone propionate on the relative bioavailability of azelastine

    Effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF).

    Measured: up to 120 h post application

Secondary outcomes (3)

  1. Relative bioavailability

    Relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP);

    Measured: up to 120 h post application

  2. Effects of fluticasone on other pharmacokinetic parameters

    Effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½);

    Measured: up to 120 h post application

  3. Adverse events

    Adverse Events.

    Measured: At and between treatment periods

Timeline

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

  1. First posted30 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

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
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190852
Sponsor's protocol ID
X-03065-3283
Other IDs
2010-019417-13
Status last verified
Apr 2016
First submitted
25 Aug 2010
Last updated
7 Feb 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azelastine, Fluticasone, Azelastine mono and Azelastine in people with Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 1 site in Germany.

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 6 inclusion and 29 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 7 Feb 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 Germany. 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?

Effect of fluticasone propionate on the relative bioavailability of azelastine (time frame: up to 120 h post application). 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 NCT01190852.

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 7 Feb 2022.

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