Could a common ED drug ease cystic fibrosis lung inflammation?

NCT ID NCT00659529

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether sildenafil (Revatio), a drug often used for erectile dysfunction, can reduce inflammation in the lungs of people with cystic fibrosis. Thirty-six participants took increasing doses over six weeks. Researchers measured changes in sputum elastase, a marker of inflammation, and other lung health indicators.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sildenafil (Revatio)
What this could lead to
If it works, this could point toward a new way to reduce lung inflammation in cystic fibrosis, potentially improving breathing and quality of life.
What could go wrong
This is an early-phase trial with only 36 people, so results may not apply widely. Sildenafil can cause side effects like headache, flushing, and low blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

36 people

The number who actually took part.

Started

Aug 2008

Finished

Dec 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of CF based on the following criteria: * Positive sweat chloride ≥60mEq/liter (by pilocarpine iontophoresis) and/or * Genotype with two identifiable mutations consistent with CF, and accompanied by one or more clinical features consistent with the CF phenotype * Male or female patients ≥ 12 years of age * FEV1 ≥ 50% predicted (Knudson) 31 * Clinically stable without evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to the screening visit * Ability to reproducibly perform spirometry (according to ATS criteria) * Ability to produce at least 1mL of sputum spontaneously, or be willing to undergo sputum induction * Ability to understand and sign a written informed consent or assent and comply with the requirements of the study * Chronic bacterial colonization (3 documented positive cultures in the prior 2 years of which at least one was obtained in the 3 months prior to randomization) Exclusion Criteria: * History of hypersensitivity to sildenafil * Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0) * Breastfeeding, pregnant, or verbal expression of unwillingness to practice an acceptable birth control method (abstinence, hormonal or barrier methods, partner sterilization or intrauterine device) during participation in the study * Daily use of systemic corticosteroids and/or NSAIDs within 4 weeks of the study or as needed use within 72 hours prior to the screening visit * History of significant hepatic (SGOT or SGPT \> 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension), cardiovascular (history of aortic stenosis, coronary artery disease, pulmonary hypertension with right ventricular systolic pressure \>55 mmHg or life-threatening arrhythmia), neurological (history of stroke), hematologic (history of bleeding diathesis), ophthalmologic (history of retinal impairment or non-arteritic ischemic optic neuritis) or renal impairment (creatinine \>1.8 mg/dL.) * Inability to swallow pills * Previous lung transplantation * Use of concomitant nitrates, α-blocker, or Ca channel blocker * Use of concomitant medications known to be potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin, rifampin) * Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data * Weight less than 40 kg * History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of screening * Resting room air oxygen saturation \<93% * History of migraines

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Conditions

The condition(s) this trial relates to.

cystic fibrosis Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Jewish Health

    Denver, Colorado, 80206, United States

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