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Molekule for Allergic Rhinitis/Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627689
Recruitment Status : Terminated (Poor accural)
First Posted : August 13, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Molekule

Tracking Information
First Submitted Date  ICMJE July 2, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE July 13, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Control of Allergic Rhinitis and Asthma Test (CARAT) score [ Time Frame: 4 weeks ]
CARAT will measure the change in control scores of respiratory allergies and asthma. Scale 0 (Worse control of allergy and asthma) to 30 (Best control of allergy and asthma). The higher score the better control of allergy and asthma. There are 10 individual questions, scoring from 0-3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Molekule for Allergic Rhinitis/Asthma
Official Title  ICMJE Molekule for Allergic Rhinitis/Asthma
Brief Summary Exposure to airborne allergens and pollutants is linked to symptom severity of allergies, asthma and other respiratory problems. In this study an air purifier using photo-electrochemical oxidation technology (PECO) will be used in the home environment of study participants. The investigator will assess the reduction of symptoms from allergic rhinitis/conjunctivitis and asthma.
Detailed Description The purpose of this study is to assess the efficacy of the portable PECO air purifier in reducing symptoms from allergic rhinitis and asthma. Using a randomized, double blinded placebo, controlled trial we will be then able to assess if there are any changes after the use of the PECO air purifier after completing an initial baseline survey & comparing to the exit survey. This is a double-blind study, which means that neither the participant nor the investigator knows which device is being used until after the trial is over.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Asthma
  • Allergic Rhinitis
  • Allergic Conjunctivitis
Intervention  ICMJE
  • Other: Active air purifier in respiratory allergies/asthma
    Continuous use of air purifier to improve allergies and asthma control
  • Other: Sham air purifier
    control arm
Study Arms  ICMJE
  • Experimental: Active air purifier arm
    Active portable air purifier for 1 month at bedside
    Intervention: Other: Active air purifier in respiratory allergies/asthma
  • Sham Comparator: Sham air purifier arm
    Placebo portable air purifier for 1 month at bedside
    Intervention: Other: Sham air purifier
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
49
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
120
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Chronic allergic rhinitis and/or conjunctivitis by history
  2. History of adult asthma requiring medications now or in the past
  3. Age ≥18
  4. CARAT score less than 24

Exclusion Criteria:

  1. Participant is <18 years-old
  2. Use of systemic corticosteroids within 14 days of study initiation
  3. Treatment with biologic agents or allergen immunotherapy
  4. Treatment with other immunomodulators (cyclosporine, azathioprine, hydroxychloroquine, etc)
  5. Sensitive to fan sound or blue/purple light at night time
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627689
Other Study ID Numbers  ICMJE Molekule-052018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Molekule
Study Sponsor  ICMJE Molekule
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nikhil G Rao, MD Molekule
PRS Account Molekule
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP