An open 4-week study to evaluate the efficacy and safety of Serroflo ® comparing with Viani ® in patients with stable persistent asthma

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004455-52-DE
• Lead Sponsor: Cipla Europe NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-28
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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ELIGIBILITY
CRITERIA
Inclusion Criteria:
1. Subjects willing to give voluntary signed informed consent.
2. Subjects of either sex between 18 and 65 years (both
inclusive) of age.
3. Able to use investigational device appropriately.
4. Subjects should have been receiving treatment with Viani ®
Evohaler 25/125 mcg for 3 months or longer and have had no
change in their asthma therapy for at least 1 month prior to
starting the study
5. ACQ = 1.0
6. General good health, and free of any concomitant conditions
or treatment that could interfere with study conduct, influence
the interpretation of study observations/results, or put the
subject at increased risk during the study.
7. Asthma diagnosis: Physician diagnosed asthma as defined
by GINA 2015.
8. Subjects with current or ex-smoking history of less than 10
pack years.
9. If female, is currently not pregnant, breast feeding, or
attempting to become pregnant, has a negative serum/urine
pregnancy test, and is of non-childbearing potential, defined
as:
? before menarche or
? >1 year post-menopausal or
? Surgically sterile (tubal ligation, bilateral oophorectomy, or
hysterectomy) or
? Congenital sterility or
? Diagnosed as infertile and not undergoing treatment to
reverse infertility
or is of Child-bearing potential, willing to commit to using a
consistent and acceptable method of birth control as defined
below for the duration of the study:
? Systemic contraception used for >1 month prior to
screening, including birth control pills, transdermal patch
(e.g., Ortho Evra ® ), vaginal ring (e.g., NuvaRing ® ), Version No 1.0: Final Eudra CT No. 2015-004455-52 Date: 14/10/2015
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levonorgesterel (e.g., Norplant ® ), or injectable
progesterone (e.g., Depo-Provera) or
? Double barrier methods (condoms, cervical cap,
diaphragm, and vaginal contraceptive film with
spermicide) or
? Intrauterine device (IUD)
or is of Child-bearing potential and not sexually active, willing
to commit to using a consistent and acceptable method of
birth control as defined above for the duration of the study, in
the event the subject becomes sexually active
10. Capable of understanding the requirements, risks, and
benefits of study participation, and as judged by the
investigator and being compliant with all study requirements
(visits, record keeping etc.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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levonorgesterel (e.g., Norplant ® ), or injectable
progesterone (e.g., Depo-Provera) or
? Double barrier methods (condoms, cervical cap,
diaphragm, and vaginal contraceptive film with
spermicide) or
? Intrauterine device (IUD)
or is of Child-bearing potential and not sexually active, willing
to commit to using a consistent and acceptable method of
birth control as defined above for the duration of the study, in
the event the subject becomes sexually active
10. Capable of understanding the requirements, risks, and
benefits of study participation, and as judged by the
investigator and being compliant with all study requirements
(visits, record keeping etc.)
Exclusion Criteria:
1. Upper respiratory tract infection or lower respiratory infection
in the past 4 weeks that has not resolved within at least 2 weeks
prior to the screening visit
2. History of known hypersensitivity or idiosyncratic reaction to
Fluticasone propionate or Salmeterol, any component of the
product or any related class of drugs (e.g., Salbutamol,
Beclomethasone dipropionate)
3. Subjects with significant, uncontrolled comorbid conditions
4. History of life-threatening asthma that is defined for this
protocol as an asthma episode that required intubation and/or
was associated with hypercapnea, respiratory arrest or hypoxic
seizures.
5. Any asthma exacerbation requiring oral corticosteroids
within 3 months prior to the Screening Visit. A subject must not
have had any hospitalization for asthma within 12 months prior
to the Screening Visit.
Note: An exacerbation of asthma is defined as any worsening
of asthma requiring the use of systemic corticosteroids and/or
emergency room visit or hospitalization.
6.Have any of the following conditions that, in the judgment of the Version No 1.0: Final Eudra CT No. 2015-004455-52 Date: 14/10/2015
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investigator, might cause participation in this study to be
detrimental to the subject, including, but not limited to:
? Current malignancy excluding basal cell carcinoma;
History of malignancy is acceptable only if the subject has
been in remission for one year prior to the Screening Visit.
(Remission is defined as no current evidence of
malignancy and no treatment for the malignancy in the 12
months prior to the Screening Visit)
? Current or untreated tuberculosis; History of tuberculosis
is acceptable only if a subject has received an approved
prophylactic treatment regimen or an approved active
treatment regimen and has had no evidence of active
disease for a minimum of 2 years
? Uncontrolled hypertension (systolic BP =160 or diastolic
BP >100)
? Stroke within 3 months prior to the Screening Visit
? Immunologic compromise
? History of a positive test for HIV, hepatitis B or hepatitis C.
? Clinical visual evidence of oral candidiasis at the
Screening Visit.
7.Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g.,
ritonavir, ketoconazole, intraconzole) within 4 weeks prior to
the Screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified