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Asthma clinical trials

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NCT ID: NCT00078208 Completed - Asthma Clinical Trials

Exhaled Breath Condensate as a Measure of Airway Inflammation in Children With Asthma

Start date: February 18, 2004
Phase: N/A
Study type: Observational

This study will evaluate the usefulness of a new procedure for evaluating asthma in children. The method measures the pH (a measure of acidity and alkalinity) of exhaled breath condensate (water vapor created by the lungs). The condensate contains products of the lungs that may be associated with lung inflammation. Investigators will determine if the pH of the exhaled breath condensate correlates well with known asthma indicators, such as number of hospitalizations, school absenteeism, use of rescue medication, and others. Test results will be compared with findings from healthy normal volunteers. No experimental treatments or medicines are used in this study. Patients who require treatment for their asthma will receive standard care with medicines approved by the Food and Drug Administration and used widely in the United States. Children with asthma and healthy normal volunteers between 6 and 17 years of age may be eligible for this study. You must complete the study before your 18th birthday. Candidates are screened with a medical history and physical examination. Children with asthma undergo the following tests and procedures over six clinic visits, including an initial visit and follow-up visits at 4-8 weeks, 3, 6, 9, and 12 months: - Blood draw in children over 6 years of age. Medications are available to decrease the pain associated with blood drawing.(initial visit) - Allergen skin testing: Drops of up to 16 allergens are placed on the arm. The skin under each drop is scratched and the area is observed for an allergic reaction. (4- 8-week follow-up visit) - Expired nitric oxide testing: The child breathes into a balloon to collect a portion of the gases exhaled form the lungs. This test measures the amount of nitric oxide, which correlates with bronchial inflammation. (all visits) - Exhaled breath condensate: The child breathes into a plastic tube surrounded by a cold metal sleeve for 10 to 15 minutes. The water vapor created by the lungs (the same vapor that forms when breathing outside on a cold day) is collected and the pH measured. (all visits) - Pulmonary (lung) function test: The child blows very hard into a tube attached to a machine to measure the airflow from the child's lungs. This test measures airflow from the lungs. (all visits) The children are given small plastic device called a peak flow meter - a device used to measure lung function - to use at home. Children whose lung function is less than 80% of the predicted value for their age may be given medicine to see if their lung function improves. - Review of the patient's symptoms, sick days, medicines or actions taken to get over the illness; review of peak flow reports; and review of action plan. (3-, 6-, 9-, and 12-month visits) Healthy controls will have the expired nitric oxide test, exhaled breath condensate test, and pulmonary function test at each visit at the initial and over two additional visits scheduled 6 months apart.

NCT ID: NCT00076076 Completed - Asthma Clinical Trials

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

NCT ID: NCT00073840 Completed - Asthma Clinical Trials

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Start date: December 2002
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

NCT ID: NCT00073827 Completed - Asthma Clinical Trials

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

NCT ID: NCT00073814 Completed - Asthma Clinical Trials

Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

Start date: December 2002
Phase: Phase 3
Study type: Interventional

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

NCT ID: NCT00073177 Completed - Asthma Clinical Trials

Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

Start date: November 2003
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

NCT ID: NCT00070707 Completed - Asthma Clinical Trials

Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)

Start date: April 3, 2003
Phase: Phase 4
Study type: Interventional

This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

NCT ID: NCT00069823 Completed - Asthma Clinical Trials

Study of Acid Reflux in Asthma

Start date: September 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

NCT ID: NCT00064389 Completed - Asthma Clinical Trials

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

Start date: January 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

NCT ID: NCT00054964 Completed - Asthma Clinical Trials

Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Start date: March 31, 2003
Phase: Phase 2
Study type: Interventional

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.