A study to look at different types and doses of medications called inhaled corticosteroids (ICS), and compare how they effect the lungs. ICS drugs are a common treatment for asthma and have an anti-inflammatory effect in the airways of the lungs.

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003002-14-DE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Age of subject: 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. Asthma: Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit.
3. Severity of disease:
a) Pre-bronchodilator FEV1= 65% of predicted at screening.
b) The pre-dose baseline FEV1 should not have changed significantly
in the opinion of the investigator from the screening baseline value
and should be = 65% predicted for the subject to continue.
c) Documented sensitivity to AMP with a provocative concentration of
AMP resulting in a fall of =20% FEV1 with a PC20 AMP =80 mg/mL
at the screening visit.
4. Current Therapy:
• Short-Acting Beta2-Agonists (SABA): prescribed SABA for at least
12 weeks prior to screening, if needed.
• Subjects receiving low-dose ICS as defined in Appendix 5 of the
study protocol may take part after a 4-week ICS washout prior to
AMP challenge. The subject’s asthma symptoms must remain
stable during this 4-week period as assessed at screening visit 2.
Stable asthma is defined as:
• No more than 2 consecutive days where =12 inhalations/day of
salbutamol were used.
• No severe asthma exacerbations requiring use of systemic
corticosteroids (tablets, suspension, or injection) or an in-patient
hospitalization or emergency department visit due to asthma
that required systemic corticosteroids.
• No clinical asthma worsening which in the opinion of the
investigator requires additional asthma treatment other than
study medication or salbutamol.
• Subjects taking LABA, LAMA, leukotriene receptor antagonist
(LTRA) therapy within 3 months prior to the start of the study are
not eligible.
• Subjects taking biological therapies within 6 months prior to start
of the study are not eligible.
5. Bodyweight and Body Mass Index (BMI): Bodyweight = 50 kg and BMI within the range 18.0-35.0 kg/m2 (inclusive)
6. Gender: Male and female.
Females:
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (HCG) test), not lactating, and at least one of the following conditions applies prior to randomization:
a. Non-reproductive potential defined as:
• Pre-menopausal females with one of the following:
• Documented tubal ligation.
• Documented hysteroscopic tubal occlusion procedure with
follow-up confirmation of bilateral tubal occlusion.
• Hysterectomy.
• Documented Bilateral Oophorectomy.
• Postmenopausal defined as 12 months of spontaneous
amenorrhea, in questionable cases a blood sample with
simultaneous follicle stimulating hormone (FSH) and estradiol
levels consistent with menopause (refer to laborator

Exclusion Criteria

1. A history of life-threatening asthma.
NOTE: Life-threatening asthma is defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
2. Other significant pulmonary diseases to include (but not limited to): severe pneumonia within 6 months of the screening visit, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma.
3. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of screening that:
• In the opinion of the investigator, is expected to affect the subject’s
asthma status or the subject’s ability to participate in the study.
4. Oropharyngeal examination: A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening.
5. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment
for asthma within 6 months prior to randomization.
6. Use of prohibited medications:
Any other medications including, anti-depressant drugs, and anti-asthma drugs (other than short acting inhaled ß-agonists supplied as rescue medication, oral contraceptives, non-steroidal anti-inflammatory drugs, stable doses of anti-histamines, and paracetamol) for 1 week prior to screening and throughout the course of the study.
Anti-histamines should be withheld 4 days prior to AMP challenge.
• Subjects must also be able to abstain from short acting inhaled
ß- agonists, for 8 hours prior to spirometry.
7. Subjects undergoing de-sensitization therapy.
8. Tobacco Use: Current smokers who smoke > 20 cigarettes per week or the equivalent unit dose of other tobacco products or e-cigarettes, or smokers with a smoking history of = 10 pack years.
9. History of regular alcohol consumption exceeding 21 units/week for men and 14 units/week for females (1 unit= 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) within 6 months of screening.
10. All subjects who are currently or in the last month have worked night-shifts are excluded from the study.
11. Previous Participation: Exposure to more than four new chemical entities within 12 months prior to the first dosing day or received an investigational product within 30 days of study start, or 5 half-lives of study drug if that is longer.
12. Other concurrent Diseases/Abnormalities: A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study. (e.g. stroke or myocardial infarction within 3 months, uncontrolled hypertension, congestive heart failure, uncontrolled diabetes mellitus.)

Study & Design

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