Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

Browse trials for

• Lung Diseases 3,303
• Signs and Symptoms, Respiratory 79

Keywords

• World Trade Center Disaster
• Environmental Exposure
• Respiratory Physiology
• Inflammation
• Gastrointestinal Diseases
• Sinus Symptoms
• PTSD
• Anxiety
• Depression
• Hypersensitivity
• Spirometry
• Oscillometry

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Study arms

• Active comparator
  Uncontrolled LRS

  Patients who have uncontrolled lower respiratory symptoms (ACT \< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.

  Drug: Fluticasone propionate 230mcg for 3 Months · Drug: Salmeterol 21mcg for 3 Months

• Other
  Controlled LRS

  Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.

  Drug: Current Treatment or no treatment

Interventions

• DrugFluticasone propionate 230mcg for 3 Months

  Also known as: Advair HFA

• DrugCurrent Treatment or no treatment

  Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.

• DrugSalmeterol 21mcg for 3 Months

Primary outcomes

1. Forced Oscillation Technique (FOT) Measures

   Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).

   Time frame: Week 12

2. Spirometry Measures

   Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters). FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity

   Time frame: Week 12

Secondary outcomes

1. Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)

   To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.

   Time frame: Week 12

2. Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)

   measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.

   Time frame: Week 12

3. Total IgE (Immunoglobulin E) Levels

   IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.

   Time frame: Week 1

4. Total EoS (Eosinophil) Counts

   EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.

   Time frame: Week 1

5. Levels of Fractional Exhaled Nitric Oxide (FeNO)

   Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.

   Time frame: Week 12

6. Score on Voice Handicap Index 10 (VHI-10)

   Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score \> 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.

   Time frame: Week 12

7. Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)

   For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).

   Time frame: Week 12

8. Score on Leicester Cough Questionnaire (LCQ)

   For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.

   Time frame: Week 12

Baseline characteristics

Publications

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330. PubMed 17983880 ↗
• Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b. PubMed 19365288 ↗
• Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC. PubMed 21642248 ↗

Study documents

• Protocol and statistical analysis plan · Dec 31, 2014

Documents are hosted by the registry — open the source record to download them.