Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma

Asthma Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of VR506 Inhaled From a New Inhaler in Adolescent and Adult Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472757
• Other study ID #: VR506/2/002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2020
• Source: Vectura Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)

• Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit

• Documented asthma reversibility in the 5 years prior to or during Screening, or if the asthma reversibility criterion is not met at Screening, then a repeat test may be carried out at the end of the Run-In Period

• Subjects with asthma who, in the opinion of the investigator, require maintenance therapy with inhaled corticosteroids (ICS), are believed to have been regularly compliant with this therapy, and are therefore likely to deteriorate within 6 weeks following withdrawal of their usual ICS treatment

• Mild or moderate asthma, defined as:

• Mild - good asthma control achieved by low-dose inhaled corticosteroid (daily dose 200-500 µg beclomethasone dipropionate or equivalent) with or without other low-intensity treatment (e.g. leukotriene modifiers or cromones) for at least 28 days before the Screening Visit

• Moderate - good asthma control achieved by low- to moderate-dose ICS (daily dose 200-1000 µg beclomethasone dipropionate or equivalent), and long acting ß2-agonist (LABA) or other extra treatment, for at least 28 days before the Screening Visit

• Ability to use the new inhaler correctly, based on investigator's review of the completed inhaler operation checklist

• Ability to use the eDiary correctly, assessed by the investigator during the Screening Period

• Ability to perform technically satisfactory pulmonary function tests

• Ability to comply with study procedures, including blood sampling

• Body mass index (BMI) of 16.0 to 26.0 kg/m2 in adolescents, and in adult subjects recruited in the Philippines, and 18.0 to 32.0 kg/m2 in adults recruited in other countries

• Available to complete all study visits

• Oral peak inspiratory flow (PIF) of at least 60 L/min; using an appropriate device set to match the resistance of the new dry powder inhaler (nDPI)

• Good health, except for the presence of asthma, according to medical history and physical examination

• Normal (i.e. non-clinically significant abnormality) 12-lead electrocardiogram (ECG)

• Negative drug, alcohol, and urine cotinine screen; subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine (unless related to nicotine-containing therapies), ethanol, and opiates (unless given as a prescription medicine)

• Non-smokers or ex-smokers with a smoking history of less than 10 pack-years (e.g. <20 cigarettes per day for 10 years or 40 cigarettes per day for 5 years) and stopped smoking for at least one year prior to the Screening Visit. Smoking will not be permitted throughout the study

• Female subjects of child-bearing potential must be using medically acceptable forms of contraception; approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, or injection, in use for =3 consecutive months before the start of the Run-In Period), double barrier (condom with spermicide, diaphragm with spermicide), intrauterine device, or vasectomised partner (=6 months since vasectomy)

Exclusion Criteria:

• Regular use (=3 times per week) of topical steroids taken to treat dermatitis, rhinitis or allergic conjunctivitis, within 28 days of the Screening Visit

• Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit

• Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months

• History of lung cancer

• Subjects with "brittle asthma", defined as patients with asthma who either maintain over many months a wide variation (>40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control

• History or current diagnosis of human immunodeficiency virus (HIV) infection

• Active chronic hepatitis B or C infection. If the patient's screening test is positive for hepatitis B surface antigen, the patient should be excluded unless the investigator, after a careful review of the patient's medical history and current laboratory tests of liver function, can exclude the possibility of recent or current infection

• Persistent arterial hypotension, with average systolic blood pressure (SBP) readings of =95 mmHg

• Subjects who have any clinically significant abnormality or finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment

• Subjects with an abnormal ECG

• Persistent elevation of blood pressure, with average SBP readings of =160 mmHg or average diastolic blood pressure (DBP) readings of =100 mmHg

• Pregnant or lactating females

• Participation in another clinical study in the 28 days prior to the Screening Visit

• Current or a history of drug or alcohol abuse or dependence according to World Health Organization criteria in the 12 months prior to the Screening Visit or evidence of such abuse as indicated by laboratory assays conducted during the screening evaluation

• Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium

• Inability to communicate well with the investigator

• Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium

• Donation of =450 mL of blood or blood products within the previous 12 weeks prior to the Screening Visit

• History of allergy, intolerance or contraindications to corticosteroids, lactose, or severe allergy to milk proteins

• Consumption of alcohol- or caffeine-containing foods or beverages from midnight before or during the Screening Visit. The visit can be rescheduled once before the subject is excluded

• History of medically diagnosed chronic respiratory diseases (other than asthma) e.g. chronic obstructive pulmonary disease

• Subjects with previously clinically or radiologically diagnosed osteoporosis and/or those receiving regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• VR506
VR506 inhalation powder delivered via a new dry powder inhaler
• Placebo
Placebo delivered via a new dry powder inhaler

Locations

Country	Name	City	State
Philippines	Vectura Clinical Trial Site 31002	Davao City
Philippines	Vectura Clinical Trial Site 31003	Iloilo City
Philippines	Vectura Clinical Trial Site 31001	Lipa City	Batangas
Philippines	Vectura Clinical Trial Site 31004	Pasig City
Philippines	Vectura Clinical Trial Site 31005	Quezon City
Philippines	Vectura Clinical Trial Site 31007	Quezon City
Poland	Vectura Clinical Trial Site 20018	Bialystok
Poland	Vectura Clinical Trial Site 20013	Biolystok
Poland	Vectura Clinical Trial Site 20015	Krakow
Poland	Vectura Clinical Trial Site 20019	Krakow
Poland	Vectura Clinical Trial Site 20007	Lodz
Poland	Vectura Clinical Trial Site 20009	Lódz
Poland	Vectura Clinical Trial Site 20012	Lublin
Poland	Vectura Clinical Trial Site 20008	Ostrów Wielkopolski
Poland	Vectura Clinical Trial Site 20003	Poznan
Poland	Vectura Clinical Trial Site 20005	Poznan
Poland	Vectura Clinical Trial Site 20016	Skiemiewice
Poland	Vectura Clinical Trial Site 20021	Tarnow
Poland	Vectura Clinical Trial Site 20010	Warszawa
Poland	Vectura Clinical Trial Site 20001	Wroclaw
Poland	Vectura Clinical Trial Site 20006	Wroclaw
Poland	Vectura Clinical Trial Site 20014	Zawadzkie
Romania	Vectura Clinical Trial Site 21002	Brasov
Romania	Vectura Clinical Trial Site 21011	Bucuresti
Romania	Vectura Clinical Trial Site 21004	Cluj-Napoca
Romania	Vectura Clinical Trial Site 21009	Cluj-Napoca
Romania	Vectura Clinical Trial Site 21010	Cluj-Napoca
Romania	Vectura Clinical Trial Site 21007	Iasi
Romania	Vectura Clinical Trial Site 21008	Iasi
Romania	Vectura Clinical Trial Site 21013	Judetul Cluj
Romania	Vectura Clinical Trial Site 21012	Judetul Iasi
Romania	Vectura Clinical Trial Site 21001	Targu-Mures
Romania	Vectura Clinical Trial Site 21005	Timisoara
Ukraine	Vectura Clinical Trial Site 23013	Donetsk
Ukraine	Vectura Clinical Trial Site 23004	Kharkiv
Ukraine	Vectura Clinical Trial Site 23005	Kharkiv
Ukraine	Vectura Clinical Trial Site 23010	Kharkiv
Ukraine	Vectura Clinical Trial Site 23002	Kiev
Ukraine	Vectura Clinical Trial Site 23009	Kiev
Ukraine	Vectura Clinical Trial Site 23011	Kiev
Ukraine	Vectura Clinical Trial Site 23012	Kiev
Ukraine	Vectura Clinical Trial Site 23017	Kiev
Ukraine	Vectura Clinical Trial Site 23001	Kyiv
Ukraine	Vectura Clinical Trial Site 23003	Kyiv
Ukraine	Vectura Clinical Trial Site 23018	Kyiv
Ukraine	Vectura Clinical Trial Site 23007	Odesa
Ukraine	Vectura Clinical Trial Site 23015	Simferopol
Ukraine	Vectura Clinical Trial Site 23014	Vinnytsya
Ukraine	Vectura Clinical Trial Site 23008	Zaporizhzhya
Ukraine	Vectura Clinical Trial Site 23016	Zaporizhzhya
United States	Vectura Clinical Trial Site 10011	Albany	Georgia
United States	Vectura Clinical Trial Site 10042	Baltimore	Maryland
United States	Vectura Clinical Trial Site 10034	Bellevue	Nebraska
United States	Vectura Clinical Trial Site 10019	Boerne	Texas
United States	Vectura Clinical Trial Site 10023	Centennial	Colorado
United States	Vectura Clinical Trial Site 10003	Charleston	South Carolina
United States	Vectura Clinical Trial Site 10001	Colorado Springs	Colorado
United States	Vectura Clinical Trial Site 10025	Denver	Colorado
United States	Vectura Clinical Trial Site 10004	Draper	Utah
United States	Vectura Clinical Trial Site 10038	Fountain Valley	California
United States	Vectura Clinical Trial Site 10031	Los Angeles	California
United States	Vectura Clinical Trial Site 10028	Medford	Oregon
United States	Vectura Clinical Trial Site 10002	Metairie	Louisiana
United States	Vectura Clinical Trial Site 10044	Mission Viejo	California
United States	Vectura Clinical Trial Site 10009	Missoula	Montana
United States	Vectura Clinical Trial Site 10029	North Dartmouth	Massachusetts
United States	Vectura Clinical Trial Site 10017	Oklahoma City	Oklahoma
United States	Vectura Clinical Trial Site 10015	Omaha	Nebraska
United States	Vectura Clinical Trial Site 10035	Omaha	Nebraska
United States	Vectura Clinical Trial Site 10022	Orange	California
United States	Vectura Clinical Trial Site 10008	Plymouth	Minnesota
United States	Vectura Clinical Trial Site 10024	Portland	Oregon
United States	Vectura Clinical Trial Site 10014	Rancho Mirage	California
United States	Vectura Clinical Trial Site 10040	Rochester	New York
United States	Vectura Clinical Trial Site 10027	Rolling Hills Estates	California
United States	Vectura Clinical Trial Site 10033	San Jose	California
United States	Vectura Clinical Trial Site 10041	Sarasota	Florida
United States	Vectura Clinical Trial Site 10010	Sylvania	Ohio
United States	Vectura Clinical Trial Site 10021	Upland	Pennsylvania
United States	Vectura Clinical Trial Site 10016	Vista	California
United States	Vectura Clinical Trial Site 10039	Waco	Texas
United States	Vectura Clinical Trial Site 10020	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vectura Limited

Countries where clinical trial is conducted

United States,  Philippines,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)		Baseline and 12 weeks
Secondary	Number of Participants With Withdrawals Due to Worsening of Asthma		12 weeks
Secondary	Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)		Baseline and 12 weeks
Secondary	Assessment of Acceptability of the Device	Percentage of subjects that overall found it very easy, fairly easy or fairy difficult to use the inhaler, based on inhaler acceptability questionnaire.	12 weeks