Diffuse Fibrotic Lung Disease

Status Completed

Clinical Trial Summary

To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.

Clinical Trial Description

BACKGROUND:

The fibrotic lung diseases represent 15 to 20 percent of the non-infectious disorders of the lung. Idiopathic pulmonary fibrosis, one of the 10 general groups of fibrotic lung disorders, is a chronic and devastating illness resulting in death within an average of 4 to 5 years from the onset of symptoms. Although 5 to 10 percent of these patients respond to corticosteroids, there is no known treatment for the remainder.

Sarcoidosis, a generalized disorder characterized by epithelioid cell granuloma formation in affected organs, especially the lung and lymphoid tissue, has a clinical course that varies considerably from patient to patient and, in some cases, resolves spontaneously. In other cases, intermittent pneumonitis develops, which may result in a permanent loss of lung function. Large intermittent doses of corticosteroids might be superior to conventional high-dose corticosteroids in patients with pulmonary sarcoidosis which has not resolved spontaneously.

DESIGN NARRATIVE:

In the randomized, non-blind cyclophosphamide versus prednisone trial, 25 to 50 patients with idiopathic pulmonary fibrosis were assigned to treatment with prednisone or cyclophosphamide. At the end of 52 weeks of drug therapy, both groups were treated using conventional medical therapies. In the non-randomized dapsone trial, 10 fibrotic patients were treated with dapsone and prednisone for one year. In the double-blind, randomized methylprednisolone trial, 25 to 50 patients were given low-dose methylprednisolone, and, in addition, all patients were randomized to either high-dose methylprednisolone treatment or to placebo at weekly intervals for one year. In the randomized, double-blind, high-dose corticosteroid trial, 25 to 50 patients with pulmonary sarcoidosis were given a short intense course of high-dose methylprednisolone or a placebo for 6 weeks.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00000596
Study type	Interventional
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	Phase 2
Start date	June 1978
Completion date	January 1983

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed	`NCT04908397` - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension	Phase 1
Terminated	`NCT03309358` - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis	Phase 1
Completed	`NCT03682354` - ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery	N/A
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Recruiting	`NCT06004440` - Real World Registry for Use of the Ion Endoluminal System
Completed	`NCT04874948` - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment	Phase 1
Completed	`NCT02926768` - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors	Phase 1
Completed	`NCT01443845` - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Phase 4
Completed	`NCT00281216` - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations	N/A
Terminated	`NCT00233207` - IC14 Antibodies to Treat Individuals With Acute Lung Injury	Phase 2
Completed	`NCT00269256` - Stress, Environment, and Genetics in Urban Children With Asthma	N/A
Recruiting	`NCT00129350` - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation	Phase 1
Active, not recruiting	`NCT00115297` - Montelukast for Early Life Wheezing	Phase 2/Phase 3
Completed	`NCT00091767` - Genetic Studies in Difficult to Treat Asthma: TENOR	N/A
Completed	`NCT00094276` - Intervention for Improving Asthma Care for Minority Children in Head Start	N/A
Completed	`NCT00069823` - Study of Acid Reflux in Asthma	Phase 3
Completed	`NCT00089752` - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea	N/A
Completed	`NCT00083798` - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.