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Trial record 65 of 150 for:    Ipratropium OR atrovent

A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial (SAPS)

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ClinicalTrials.gov Identifier: NCT01696214
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : October 12, 2016
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joe Ramsdell, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Fluticasone 250 mg/salmeterol 50 mg
Drug: Montelukast 10mg
Drug: Theophylline 400 mg
Drug: ipratropium
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Hide Arm/Group Description

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.

Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.

Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.

Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.

Fluticasone 250 mg/salmeterol 50 mg:

Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50

Period Title: Overall Study
Started 5 5 5 5
Completed 4 5 5 5
Not Completed 1 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg Total
Hide Arm/Group Description

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.

Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.

Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.

Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.

Fluticasone 250 mg/salmeterol 50 mg:

Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50

Total of all reporting groups
Overall Number of Baseline Participants 4 5 5 5 19
Hide Baseline Analysis Population Description
smoking asthmatics
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 5 participants 5 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
5
 100.0%
5
 100.0%
5
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 5 participants 5 participants 19 participants
49
(42 to 50)
48
(44 to 50)
39
(28 to 50)
28
(26 to 50)
41
(26 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 5 participants 5 participants 19 participants
Female
4
 100.0%
2
  40.0%
3
  60.0%
1
  20.0%
10
  52.6%
Male
0
   0.0%
3
  60.0%
2
  40.0%
4
  80.0%
9
  47.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 5 participants 5 participants 19 participants
4 5 5 5 19
1.Primary Outcome
Title Asthma Control Test
Hide Description The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
Time Frame Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Hide Arm/Group Description:

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.

ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.

Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.

Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.

Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

Overall Number of Participants Analyzed 4 5 5 5
Median (Full Range)
Unit of Measure: units on a scale
17.5
(13 to 19)
13
(7 to 19)
12
(9 to 15)
10
(5 to 13)
2.Secondary Outcome
Title The Asthma Symptom Utility Index (ASUI)
Hide Description The Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation.
Time Frame Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Hide Arm/Group Description:

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.

ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.

Theophylline 400 mg: Participants will be assigned to theophylline once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.

Montelukast 10mg: Participants will be assigned to montelukast once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.

Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

Overall Number of Participants Analyzed 4 5 5 5
Median (Standard Deviation)
Unit of Measure: units on a scale
0.16  (0.07) 0.24  (0.20) 0.14  (0.15) 0.13  (0.18)
3.Secondary Outcome
Title Percent (%) Perdicted FEV1 Changes
Hide Description Physiologic measures of % predicted FEV1
Time Frame Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Hide Arm/Group Description:

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.

Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.

Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.

Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.

Fluticasone 250 mg/salmeterol 50 mg:

Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50

Overall Number of Participants Analyzed 4 5 5 5
Median (Standard Deviation)
Unit of Measure: percent predicted FEV1
-1.62  (7.89) 4.73  (7.72) 0.87  (10.57) -5.71  (5.24)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Hide Arm/Group Description

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.

Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.

Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks

Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.

Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.

Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.

Fluticasone 250 mg/salmeterol 50 mg:

Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50

All-Cause Mortality
Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/5 (0.00%)      1/5 (20.00%)      0/5 (0.00%)    
Respiratory, thoracic and mediastinal disorders         
asthma exacerbation * [1]  0/4 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
Social circumstances         
death * [2]  0/4 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Participant hospitalized overnight with asthma exacerbation. Study drug stopped while overnight hospitalization and continued with randomized study drug and completed double blind portion of study.
[2]
Participant in the run-out phase with open label Advair 100/50 and was found dead. Autopsy found cause of that to be due to Phencyclidine and Cocaine Toxicity
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ipratropium Theophylline Montelukast Fluticasone 250 mg/Salmeterol 50mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      5/5 (100.00%)      5/5 (100.00%)      5/5 (100.00%)    
Cardiac disorders         
tachycardia * [1]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 1/5 (20.00%)  1
Eye disorders         
iritis * [2]  0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
Gastrointestinal disorders         
nausea * [3]  0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1
diarrhea * [4]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
constipation * [5]  0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
General disorders         
drowsiness * [6]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
dry mouth * [7]  1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0
edema * [8]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations         
viral infection * [9]  4/5 (80.00%)  4 1/5 (20.00%)  1 1/5 (20.00%)  1 3/5 (60.00%)  3
Musculoskeletal and connective tissue disorders         
back pain * [10]  1/5 (20.00%)  2 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
chest pain * [11]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
headache * [12]  0/5 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1 1/5 (20.00%)  1
swollen hand * [13]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
sprained finger * [14]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders         
migraine headache * [15]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
Renal and urinary disorders         
urinary tract infection * [16]  0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders         
rash * [17]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
skin lesion * [18]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1
pruritus * [19]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
Social circumstances         
motor vehicle accident * [20]  0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
transient tachycardia
[2]
transient viral
[3]
transient nausea
[4]
transient diarrhea
[5]
transient constipation
[6]
transient drowsiness
[7]
transient dry mouth
[8]
mild transient edema
[9]
self-limiting viral infection
[10]
transient back pain
[11]
transient chest wall discomfort
[12]
musculoskeletal headache
[13]
transient swollen hand
[14]
sprained finger, recovered without difficulty
[15]
migraine headache
[16]
treated urinary tract infection with no recurrence
[17]
transient rash
[18]
stable keratosis
[19]
transient lower extremity itching
[20]
motor vehicle accident with no serious injury
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joe Ramsdell
Organization: University of California San Diego
Phone: 619-543-7241
EMail: jramsdell@ucsd.edu
Layout table for additonal information
Responsible Party: Joe Ramsdell, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01696214     History of Changes
Other Study ID Numbers: ARCTC-09
IR34HL109482-01A1 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute (NHLBI) )
First Submitted: June 25, 2012
First Posted: September 28, 2012
Results First Submitted: August 8, 2016
Results First Posted: October 12, 2016
Last Update Posted: January 23, 2019