Cough Clinical Trial
Official title:
An Open-label, Non-drug Methodology Trial to Evaluate the Use of a Mouthpiece With the VR647 Inhalation System During Delivery of Isotonic Saline (0.9% NaCl) in Subjects Less Than Five Years of Age Who Have Previously Received an Inhaled Therapy Delivered Either by a Nebulizer or by a Pressurized Metered-dose Inhaler Plus Spacer
Verified date | July 2019 |
Source | Vectura Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, non-drug methodology trial in which subjects undergo a stepwise series
of tests to evaluate their ability to use a mouthpiece to deliver nebulized therapy.
The trial consists of a screening assessment and familiarization session, and two
nebulization assessments, conducted over two site visits. The screening assessment,
familiarization session and first nebulization assessment will take place at Visit 1, while
the second nebulization assessment will take place at Visit 2. The total duration between
Visits 1 and 2 will be 4 - 8 days. Each visit is expected to last up to 2 hours.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 20, 2018 |
Est. primary completion date | February 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 5 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects aged 1 to <5 years - History of coughing and/or recurrent wheezing within the last year, otherwise healthy - Use of an inhaler with a spacer or nebulizer for at least 30 days (consecutive or otherwise) within the last year. Examples of inhaled or nebulized therapy include the use of a regular controller (inhaled corticosteroids (ICS) or ICS/long-acting beta-agonists), or a reliever therapy (e.g., albuterol) on an as needed basis for the relief of symptoms - Written informed consent from the subjects's parent(s)/legal guardian(s), including privacy authorization, prior to trial participation - Subject's parent(s)/legal guardian(s) must be willing and able to comply with the trial procedures and visit schedules Exclusion Criteria: Screening (Visit 1) - Any significant medical conditions (apart from a history of coughing and/or recurrent wheezing) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures - Subjects with current respiratory symptoms or breathing difficulties at the time of screening - History of paradoxical bronchospasm or hyper-responsiveness following inhaled therapy that in the opinion of investigator may put the subject at risk when inhaling isotonic saline - Parent(s)/legal guardian(s) who is an employee of the investigational site or the Sponsor, who is directly involved in the trial, or a family member of such a person Nebulization Assessment 2 (Visit 2) - Development of any new illness or condition between the Screening (Visit 1) and prior to Nebulization Assessment 2 (Visit 2) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures - Any safety concerns that in the opinion of the investigator would jeopardize the subject by his/her continued participation in the trial |
Country | Name | City | State |
---|---|---|---|
United States | National Allergy and Asthma Research, LLC | Charleston | South Carolina |
United States | Allergy & Asthma Associates of Southern California | Mission Viejo | California |
United States | Clinical Research Institute, Inc | Plymouth | Minnesota |
United States | North Carolina Clinical Research | Raleigh | North Carolina |
United States | St. Louis Children's Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Vectura Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit. | Nebulization success using a mouthpiece defined as actuating the nebulizer on at least 70% of planned inhalations and inhaling at least 50% of the total intended inhalation volume. | 4 to 8 days | |
Secondary | Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit. | Number of breaths completed by subjects using a mouthpiece recorded at each visit. | 4 to 8 days | |
Secondary | Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 at each visit. | Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist. | 4 to 8 days | |
Secondary | Number of subjects who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 overall and by age (years) at each visit. | Number of subjects who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist. | 4 to 8 days | |
Secondary | The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit. | The inhalation checklist consists of 5 questions regarding inhalation quality answered Yes/No (Q1, Q2, Q3 and Q5) or by percentage (Q4), with Yes answers for Q1-3 and >50% for Q4 (or Yes answers for Q1-3 and Q5 in the successful subgroup analysis) being scored as perfect. | 4 to 8 days | |
Secondary | Mean modified Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. The first 8 questions generate the total score domain (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 14.3 to 100, calculated as ((Q1+Q2+Q3+Q4+Q5+Q6+Q7+Q8)/56)*100). | 4 to 8 days | |
Secondary | Mean modified PASAPQ satisfaction score at Attempt 3 at Visit 2 overall and by age (years). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 9 asks for overall satisfaction with the device(s) used in the trial (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 1-7). | 4 to 8 days | |
Secondary | Mean modified PASAPQ score indicating willingness to continue with the device at Attempt 3 at Visit 2 overall and by age (years). | The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 10 asks about willingness to continue with the device(s) used in the trial (scale: 0 (i.e, not willing) to 100 (i.e., definitely willing; range: 0-100). | 4 to 8 days |
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